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Proposed Rule2023-18781

Medicare and Medicaid Programs; Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting

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Published

September 6, 2023

Issuing agencies

Health and Human Services DepartmentCenters for Medicare & Medicaid Services

Abstract

This proposed rule would establish minimum staffing standards for long-term care facilities, as part of the Biden-Harris Administration's Nursing Home Reform initiative to ensure safe and quality care in long-term care facilities. In addition, this rule proposes to require States to report the percent of Medicaid payments for certain Medicaid-covered institutional services that are spent on compensation for direct care workers and support staff.

Full Text

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<title>Federal Register, Volume 88 Issue 171 (Wednesday, September 6, 2023)</title>
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[Federal Register Volume 88, Number 171 (Wednesday, September 6, 2023)]
[Proposed Rules]
[Pages 61352-61429]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-18781]

[[Page 61351]]

Vol. 88

Wednesday,

No. 171

September 6, 2023

Part III

Department of Health and Human Services

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Centers for Medicare & Medicaid Services

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42 CFR Parts 438, 442, et al.

Medicare and Medicaid Programs; Minimum Staffing Standards for Long-
Term Care Facilities and Medicaid Institutional Payment Transparency
Reporting; Proposed Rule

Federal Register / Vol. 88 , No. 171 / Wednesday, September 6, 2023 /
Proposed Rules

[[Page 61352]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 438, 442, and 483

[CMS-3442-P]
RIN 0938-AV25

Medicare and Medicaid Programs; Minimum Staffing Standards for
Long-Term Care Facilities and Medicaid Institutional Payment
Transparency Reporting

AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).

ACTION: Proposed rule.

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SUMMARY: This proposed rule would establish minimum staffing standards
for long-term care facilities, as part of the Biden-Harris
Administration's Nursing Home Reform initiative to ensure safe and
quality care in long-term care facilities. In addition, this rule
proposes to require States to report the percent of Medicaid payments
for certain Medicaid-covered institutional services that are spent on
compensation for direct care workers and support staff.

DATES: To be assured consideration, comments must be received at one of
the addresses provided below, by November 6, 2023.

ADDRESSES: In commenting, please refer to file code CMS-3442-P.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-3442-P, P.O. Box 8016,
Baltimore, MD 21244-8016.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-3442-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: The Clinical Standard Group's Long
Term Care Team at <a href="/cdn-cgi/l/email-protection#a5edc0c4c9d1cdc4cbc1f6c4c3c0d1dceccbd4d0ccd7ccc0d6e5c6c8d68bcdcdd68bc2cad3">[email&#160;protected]</a> for information
related to the minimum staffing standards.
Anne Blackfield, (410) 786-8518, for information related to
Medicaid institutional payment transparency reporting.

SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the search instructions on that website to
view public comments. CMS will not post on <a href="http://Regulations.gov">Regulations.gov</a> public
comments that make threats to individuals or institutions or suggest
that the individual will take actions to harm the individual. CMS
continues to encourage individuals not to submit duplicative comments.
We will post acceptable comments from multiple unique commenters even
if the content is identical or nearly identical to other comments.
To assist readers in referencing sections contained in this
document, we are providing the following Table of Contents.

Table of Contents

I. Executive Summary
A. Purpose
B. Summary of Major Provisions
C. Summary of Cost and Benefits
II. Minimum Staffing Standards for Nursing Homes in Response to the
Presidential Initiative
A. Background
B. Provisions of the Proposed Regulations
III. Medicaid Institutional Payment Transparency Reporting Provision
IV. Collection of Information Requirements
V. Response to Comments
VI. Regulatory Impact Analysis

I. Executive Summary

A. Purpose

This proposed rule would establish minimum staffing standards to
address ongoing safety and quality concerns for the 1.4 million \1\
residents receiving care in Medicare and Medicaid certified Long-Term
Care (LTC) facilities. On February 28, 2022, President Biden announced
that CMS would propose minimum staffing standards that nursing homes
must meet, based in part on evidence from a new research study that
will focus on the level and type of staffing needed to ensure safe and
quality care.\2\ In addition, on April 18, 2023, President Biden issued
``Executive Order on Increasing Access to High-Quality Care and
Supporting Caregivers'',\3\ which directs the Secretary of HHS to
consider actions to encourage LTC facilities to reduce nursing staff
turnover that is associated with improving safety and quality of
care.4 5
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\1\ <a href="https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-service-type-reports/cms-program-statistics-medicare-skilled-nursing-facility">https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-service-type-reports/cms-program-statistics-medicare-skilled-nursing-facility</a>.
\2\ <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2022/02/28/fact-sheet-protecting-seniors-and-people-with-disabilities-by-improving-safety-and-quality-of-care-in-the-nations-nursing-homes/">https://www.whitehouse.gov/briefing-room/statements-releases/2022/02/28/fact-sheet-protecting-seniors-and-people-with-disabilities-by-improving-safety-and-quality-of-care-in-the-nations-nursing-homes/</a>.
\3\ Executive Order on Increasing Access to High Quality Care
and Supporting Caregivers. White House. Accessed at <a href="https://www.whitehouse.gov/briefing-room/presidential-actions/2023/04/18/executive-order-on-increasing-access-to-high-quality-care-and-supporting-caregivers/">https://www.whitehouse.gov/briefing-room/presidential-actions/2023/04/18/executive-order-on-increasing-access-to-high-quality-care-and-supporting-caregivers/</a>. Published on April 18, 2023. Accessed on
April 19, 2023.
\4\ Zheng, Q, Williams, CS, Shulman, ET, White, AJ. Association
between staff turnover and nursing home quality--evidence from
payroll-based journal data. J Am Geriatr Soc. 2022; 70(9): 2508-
2516. doi:10.1111/jgs.17843.
\5\ Castle, Nicholas G, and John Engberg. ``Staff turnover and
quality of care in nursing homes.'' Medical care vol. 43,6 (2005):
616-26. doi:10.1097/01.mlr.0000163661.67170.b9.
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These safety and quality concerns stem, at least in part, from
chronic understaffing in LTC facilities, and are particularly
associated with insufficient numbers of registered nurses (RNs) and
nurse aides (NAs), as evidenced from, inter alia, a review of data
collected since 2016 and lessons learned during the COVID-19 Public
Health Emergency (PHE). Numerous studies, including our new research
study as well as existing literature, have shown that staffing levels
are closely correlated with the quality of care that LTC facility
residents receive, and with improved health outcomes. The minimum
staffing standards would also provide staff in LTC facilities the
support they need to safely care for residents, help prevent staff--
burnout, thereby reducing staff turnover, which can lead to improved
safety and quality for residents and staff. This proposed rule would
also promote public transparency related to the percent of Medicaid
payments for certain institutional services that are spent on
compensation to direct care workers and support staff.

B. Summary of Major Provisions

We are proposing to update the Federal participation ``Requirements
for Medicare and Medicaid Long Term Care Facilities'' minimum staffing
standards (``LTC requirements''). The updates to

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the LTC requirements proposed in this rule would be used to survey
facilities for compliance and enforced as part of CMS's existing
survey, certification, and enforcement process for LTC facilities. In
addition, consistent with the President's strategic plan, we also
intend to display our determinations of facility compliance with the
minimum staffing standards on Care Compare. We welcome comments on the
most appropriate approach for doing so.
We are proposing to establish Federal minimum nurse staffing
standards for a number of reasons, including the growing body of
evidence demonstrating the importance of staffing to resident health
and safety, continued insufficient staffing, non-compliance by a subset
of facilities, the need to reduce variability in the minimum floor for
nurse-to-resident ratios across States by creating a consistent floor,
and, most importantly, to reduce the risk of residents receiving unsafe
and low-quality care.
The proposed regulatory updates are based on evidence we collected
using a multifaceted approach, which included conducting a new nursing
home staffing study, gathering feedback during listening sessions,
considering more than 3,000 comments received from the Fiscal Year 2023
Skilled Nursing Facility Prospective Payment System proposed rule
(FY2023 SNF PPS) request for information (RFI), assessing Payroll-Based
Journal (PBJ) System data on nursing home staffing, and reviewing the
existing literature.
Specifically, we propose to revise Sec. 483.35(b) to require an RN
to be on site 24 hours per day and 7 days per week to provide skilled
nursing care to all residents in accordance with resident care plans.
We also propose individual minimum staffing type standards, based on
case-mix adjusted data for RNs and NAs, to supplement the existing
``Nursing Services'' requirements at 42 CFR 483.35(a)(1)(i) and (ii) to
specify that facilities must provide, at a minimum, 0.55 RN hours per
resident day (HPRD) and 2.45 NA HPRD. We note that while the 0.55 and
2.45 HPRD standards were developed using case-mix adjusted data
sources, the standards themselves will be implemented and enforced
independent of a facility's case-mix. In other words, facilities must
meet the 0.55 RN and 2.45 NA HPRD standards, at a minimum, regardless
of the individual facility's patient case-mix. RN and NA staffing can
never be lower than these proposed minimum standards, and if the acuity
needs of residents in a facility require a higher level of care, a
higher RN and NA staffing level will also be required. CMS is also
seeking comments on whether in addition to the 0.55 RN and 2.45 NA HPRD
standards, a minimum total nurse staffing standard, discussed later in
the rule, should also be required. For compliance, hours per resident
day (HPRD) is defined as staffing hours per resident per day which is
the total number of hours worked by each type of staff divided by the
total number of residents as calculated by the CMS. As further
described below, the proposed minimum staffing standard is supported by
literature evidence, analysis of staffing data and health outcomes,
discussions with residents, staff, and industry \6\ and other factors.
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\6\ Abt Associates. (2022). Nursing Home Staffing Study
Comprehensive report. Report prepared for the Centers for Medicare &
Medicaid Services. <a href="https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf">https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf</a>.
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We note that each of the minimum staffing requirements
independently supports resident health and safety. Therefore,
compliance with the 24/7 RN requirement does not imply compliance with
the minimum 0.55 RN HPRD and 2.45 NA HPRD requirements or vice versa.
Specifically, as discussed elsewhere in this rule, the presence of an
RN in a LTC facility on a 24-hour basis improves overall quality of
care. Similarly, but separately, a minimum number of RN and NA hours
per resident per day improve overall quality of care. Both
independently and collaboratively, these requirements would support
compliance with statutory mandates to provide services to attain or
maintain the highest practicable physical, mental, and psychosocial
well-being of each resident, in accordance with a written plan of care.
As noted elsewhere, this proposal is informed by multiple sources
of information, including the 2022 Nursing Home Staffing Study, more
than 3,000 public comment submissions, academic and other literature,
PBJ System data, and detailed listening sessions with residents and
their families, workers, health care providers, and advocacy groups. We
recognize that some of the materials we have relied upon offer support
for a higher minimum HPRD standard. For several reasons discussed later
in this proposed rule, including the importance of setting achievable
staffing targets as the long-term care sector recovers from the effects
of the COVID-19 pandemic and the desire to preserve resident access to
care as the sector expands hiring to meet staffing standards, we are
proposing a set of policies that balance the urgent need to improve
resident safety and quality of care alongside these practical
considerations. The policies include minimum HPRD standards for direct
care by nursing staff, required access to an RN 24 hours per day 7 days
per week, and enhanced facility staffing assessments.
For example, the 2022 Nursing Home Staffing Study found that a
total nurse staffing level of 3.67 or 3.88 HPRD was linked with
additional facilities improving quality and safety relative to current
low performers, and that total nurse staffing levels between 3.8 HPRD
and 4.6 HPRD (including 1.4 licensed nurse HPRD) were linked with
reductions in the amount of delayed or omitted clinical care. Our
proposal squares these associations between higher HPRD nurse staffing
levels and better care outcomes with the goal of establishing
implementable minimum standards that can substantially improve quality
and safety at all LTC facilities in the near-term. We also considered
variation and contradiction between different information sources,
including the 2022 Nursing Home Staffing Study, namely regarding the
benefits of a staffing standard inclusive of or specific to LPN/LVNs.
We further considered the benefits of a requirement for 24/7 on-site RN
staffing and strengthened facility staffing assessments, which under
this proposed rule apply independently of the HPRD requirements.
The resulting, evidence-based proposal appropriately prioritizes
quality and safety of care gains from establishing minimum standards
for RNs and NAs, with a particular emphasis on the direct care
delivered at the bedside by NAs, and effective implementation of these
new requirements. As noted elsewhere, if finalized, these new required
floors would increase staffing in more than 75 percent of nursing
facilities nationwide, and the proposed NA and RN HPRD requirements
exceed those of nearly all States. We remain committed to continued
examination of staffing thresholds, including careful work to review
quality and safety data resulting from initial implementation of
finalized policies, and robust public engagement. Should subsequent
data indicate that additional increases to staffing minimums would be
warranted and feasible, we anticipate that we will revisit the minimum
staffing standards to shift them toward the higher ranges supported by
the evidence, such as those described above, with continued
consideration of all relevant factors.
We also propose to revise the existing Facility Assessment
requirements at Sec. 483.70(e) by moving the provisions to a
standalone section and modifying the

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requirements to ensure that facilities have an efficient process for
consistently assessing and documenting the necessary resources and
staff that the facility requires to provide ongoing care for its
population that is based on the specific needs of its residents.
We are proposing to stagger the implementation dates of these
requirements sufficiently to allow facilities the time needed to
prepare and be in compliance with the new requirements. Specifically,
we propose that the RN on site, 24 hours per day, for 7 days a week
would take effect 2 years after publication of the final rule; and we
propose that the individual minimum standards of 0.55 HPRD for RNs and
2.45 HPRD for NAs would take effect 3 years after publication of the
final rule. Under the proposal facilities in rural areas would be
required to meet the proposed RN on site 24 hours per day, for 7 days a
week, 3 years after publication of the final rule; and the proposed
minimum standards of 0.55 HPRD for RNs and 2.45 HPRD for NAs would take
effect 5 years after publication of the final rule.
Exemption from the proposed minimum standards of 0.55 HPRD for RNs
and 2.45 HPRD for NAs would be available only in limited circumstances,
where all four of the following criteria are met. The four exemption
criteria are: (1) where workforce is unavailable, or the facility is at
least 20 miles from another long-term care facility, as determined by
CMS; (2) the facility is making a good faith effort to hire and retain
staff; (3) the facility provides documentation of its financial
commitment to staffing; and (4) the facility has not failed to submit
PBJ data in accordance with re-designated 483.70(p), is not a Special
Focus Facility (SFF); has not been cited for widespread insufficient
staffing with resultant resident actual harm or a pattern of
insufficient staffing with resultant resident actual harm, as
determined by CMS; and has not been cited at the ``immediate jeopardy''
level of severity with respect to insufficient staffing within the 12
months preceding the survey during which the facility's non-compliance
is identified.
If finalized, enforcement actions, also called remedies, would be
taken against LTC facilities that are not in compliance with these
Federal participation requirements. The remedies CMS may impose
include, but are not be limited to, the termination of the provider
agreement, denial of payment for all Medicare and/or Medicaid
individuals by CMS, and/or civil money penalties.
We are also proposing new regulations at 42 CFR 442.43 (with a
cross-reference at 42 CFR 438.82) that would require that State
Medicaid agencies report on the percent of payments for Medicaid-
covered services in nursing facilities and intermediate care facilities
for individuals with intellectual disabilities (ICF/IIDs) that are
spent on compensation for direct care workers and support staff. This
proposal is designed to inform efforts to address the link between
sufficient payments being received by the institutional direct care and
support staff workforce and access to and, ultimately, the quality of
services received by Medicaid beneficiaries. Taken together, we believe
that these proposals will improve safety and quality of care for
residents in Medicare and Medicaid certified LTC facilities and
Medicaid certified ICF/IIDs.

C. Summary of Cost and Benefits

Table 1--Cost and Benefits
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Provision description Total transfers/costs
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Comprehensive Staffing Requirement for Without accounting for any
LTC Facilities. exemptions, we estimate that
the overall economic impact
for the proposed minimum
staffing requirements for LTC
facilities (that is,
collection of information
costs and compliance with the
24/7 RN, facility assessment,
and minimum 0.55 RN and 2.45
NA HPRD requirements), which
includes staggered
implementation of the
requirements, would result in
an estimated cost of
approximately for $32 million
in year 1; $246 million in
year 2; $4 billion in year 3;
with costs increasing to $5.7
billion by year 10. We
estimate the total cost over
10 years will be $40.6
billion, which was derived
from FY 2021 Part V of the
Medicare Cost Report. LTC
facilities would be expected
to bear the burden of these
costs, unless payors increase
rates to cover cost.
Quantified benefits include
but are not limited to,
increased community
discharges, reduced
hospitalizations, and
emergency department visits,
with a minimum estimated
savings of gross costs of $318
million per year for Medicare
starting in year 3. Various
categories of other important
but hard to quantify benefits
include reduced staff burnout
and turnover, and increased
safety and quality of care for
LTC residents. Lack of
quantification is also
noteworthy as regards key
categories of costs.
Medicaid Institutional Payment The overall economic impact for
Transparency Reporting. the proposed reporting
requirement is a one time cost
of $38 million and ongoing
annual costs of $18 million
per year.
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II. Minimum Staffing Standards for Long-Term Care Facilities

A. Background

1. Statutory Authority and Regulatory Requirements for Direct Care
Nurse Staffing in Long-Term-Care (LTC) Facilities
Sections 1819 and 1919 of the Social Security Act (the Act) set out
regulatory requirements for Medicare and Medicaid long-term care
facilities, respectively. Specific statutory language at sections
1819(d)(4)(B) and 1919(d)(4)(B) of the Act permit the Secretary of the
Department of Health and Human Services (the Secretary) to establish
any additional requirements relating to the health, safety, and well-
being \7\ of residents in skilled nursing facilities (SNF) and nursing
facilities (NF), as the Secretary finds necessary. This provision and
other statutory authorities set out in section 1819 and

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1919 of the Act provide CMS with the authority to issue a regulation
revising the existing requirements and to mandate a staffing minimum
for nursing care. Under sections 1866 and 1902 of the Act, providers of
services in Long Term Care (LTC) facilities seeking to participate in
the Medicare or Medicaid program, or both, must enter into an agreement
with the Secretary or the State Medicaid agency, respectively. LTC
facilities seeking to be Medicare or Medicaid providers of services
must be certified as meeting Federal participation requirements. These
Federal participation requirements are the basis for survey activities
in LTC facilities for ensuring residents' minimum health and safety
requirements are met and maintained, to receive payment and remain in
the Medicare or Medicaid program or both. LTC facilities include SNFs
for Medicare and NFs for Medicaid. The Federal participation
requirements for SNFs, NFs, or dually certified facilities, are
codified in the implementing regulations at 42 CFR part 483, subpart B.
In addition to those provisions, sections 1819(b)(1)(A) and
1919(b)(1)(A) of the Act require that a SNF or NF must care for its
residents in such a manner and in such an environment as will promote
maintenance or enhancement of the safety and quality of life of each
resident. Section 1819(b)(4)(C)(i) of the Act requires that a SNF must
provide 24-hour licensed nursing services, sufficient to meet the
nursing needs of its residents, and must use the services of a
registered professional nurse at least 8 consecutive hours a day. These
provisions are largely paralleled at section 1919(b)(4)(C)(i) of the
Act for NFs. Sections 1819(f)(1) and 1919 (f)(1) of the Act require
that the Secretary assure that requirements which govern the provision
of care in skilled nursing facilities under this title, and the
enforcement of such requirements, are adequate to protect the health,
safety, welfare, and rights of residents and to promote the effective
and efficient use of public moneys.
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\7\ Section 1819(d)(4)(B) of the Act contains the word ``well-
being'', which does not appear in section 1919(d)(4)(B). We do not
interpret the presence of this word as requiring separate regulatory
treatment of Medicare and Medicaid long term care facilities.
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In addition, sections 1819(b)(2) and 1919(b)(2) of the Act require
that a SNF or NF provide services to attain or maintain the highest
practicable physical, mental, and psychosocial well-being of each
resident, in accordance with a written plan of care. The plan of care
must describe the medical, nursing, and psychosocial needs of the
resident and how the needs will be met. The plan of care is developed
with the resident or resident's family or legal representative, and by
a team which includes the resident's attending physician and an RN with
responsibility for the resident. The plan of care should be
periodically reviewed and revised by the team after required
assessments. Sections 1819(b)(3) and 1919(b)(3) of the Act require that
a SNF or NF conduct a comprehensive, accurate, standardized,
reproducible assessment of each resident's functional capacity.
Assessments are required to be conducted or coordinated by a registered
nurse at specified frequencies.
The participation requirements for LTC facilities (Federal
requirements) are set forth at Sec. Sec. 483.1 through 483.95. In
general, the health and safety standards for LTC facilities address
facility administration, resident rights, care planning, quality
assessment, performance improvement, services provided, emergency
preparedness, as well as staffing requirements. Federal requirements
state that LTC facilities must use the services of a registered nurse
(RN) for at least 8 consecutive hours a day, 7 days a week (Sec.
483.35(b)(1)), and must provide the services of ``sufficient numbers''
of licensed nurses and other nursing personnel, which includes but is
not limited to nurse aides (NAs), 24 hours a day to provide nursing
care to all residents in accordance with the resident care plans (Sec.
483.35(a)(1)). The LTC facility must also designate an RN to serve as
the director of nursing (DON) on a full-time basis (Sec.
483.35(b)(2)).
While these Federal requirements do specify a specific number of
hours that these licensed nurses and other nursing personnel must be
available, there is no requirement that those hours be specifically
dedicated to direct resident care. With respect to staffing
requirements specific to individual residents, such as RN staffing
levels per resident, Federal regulations currently require that
facilities provide staff sufficient to ``assure resident safety and
attain or maintain the highest practicable physical, mental, and
psychosocial well-being of each resident''. Facilities should determine
whether this is met through ``resident assessments and individual plans
of care and considering the number, acuity, and diagnoses or the
facility's resident population'' (Sec. Sec. 483.35 and 483.70(e)).
2. The Need for a Minimum Nurse Staffing Requirement in LTC Facilities
On October 4, 2016, we issued a final rule titled, ``Medicare and
Medicaid Programs; Reform of Requirements for Long-Term Care
Facilities'' (81 FR 68688). This final rule significantly revised the
list of requirements that LTC facilities must meet to participate in
the Medicare and Medicaid programs. Prior to the final rule, LTC
facilities' requirements had not been comprehensively reviewed and
updated since 1991 (56 FR 48826, September 26, 1991), despite
substantial changes in service delivery in this setting. The final rule
included revisions that reflect advances in the theory and practice of
LTC service delivery and safety. The various revisions sought to
achieve broad-based improvements in the quality of care provided in LTC
facilities and in resident safety. As part of this 2016 final rule, we
revised LTC facilities requirements to include competency requirements
for determining the sufficiency of nursing staff, based on a facility
assessment requirement that LTC facilities must conduct to determine
what resources are needed to competently care for their residents
during both day-to-day operations and emergencies. In the 2015 proposed
rule, we included a robust discussion regarding the long-standing
interest in increasing the required hours of nurse staffing per day and
the various literature surrounding the issue of minimum nurse staffing
standards in LTC facilities (see 80 FR 42199). In the 2016 final rule,
we also included a discussion of the feedback received regarding our
competency-based staffing approach (see 81 FR 68688). At the time, we
highlighted the importance of establishing national staffing standards
to promote safe, high- quality care for residents in LTC facilities and
our desire to further explore potential options, however we noted that
we needed additional evidence before pursuing potential requirements.
We acknowledged that additional literature evidence along with data
from sources such as Payroll Based Journal (PBJ) System would be
helpful in determining if and what staffing levels should be
established as minimum staffing standards to improve safety and the
quality of care.\8\ Additionally, the availability of PBJ System data
is essential to adequately enforcing oversight of minimum staffing
standards. Since issuing the 2016 final rule and establishing a
competency-based approach to staffing in the list of LTC requirements,
we have collected several years of mandated PBJ System data and new
evidence from the literature.
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\8\ <a href="https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/Staffing-Data-Submission-PBJ">https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/Staffing-Data-Submission-PBJ</a>.

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[[Page 61356]]

Additionally, as a part of the FY 2023 Skilled Nursing Facility
Prospective Payment System Proposed Rule Request for Information (FY
2023 SNF PPS RFI) discussed later in this proposed rule, commenters
provided examples of ongoing quality and safety concerns within
understaffed LTC facilities. These included, but are not limited to,
residents going entire shifts without receiving toileting or days
without bathing assistance, increases in falls, residents not receiving
basic feeding or changing services, and even abuse in cases where no
one was watching. The 2022 Nursing Home Staffing Study (also discussed
later in this proposed rule) corroborated these comments and identified
that basic care tasks, such as bathing, toileting, and mobility
assistance, are often delayed when LTC facilities are understaffed.
Interviews with various nurse staff highlighted ongoing concerns that
care is often rushed, including for high-acuity residents, which can
often lead to errors or safety issues.
The COVID-19 Public Health Emergency (PHE) highlighted and
exacerbated the long-standing concerns with inadequate staffing in LTC
facilities. However, the COVID-19 PHE also yielded evidence that
appropriate staffing made a difference as a part of the overall
response to the COVID-19 PHE in LTC facilities. The Centers for Disease
Control and Prevention (CDC) noted that nursing home residents were at
high risk for infection, serious illness, and death from the COVID-19
infection and Medicare beneficiaries were disproportionately impacted
by the COVID-19 infection, with 76 percent of COVID-19 related deaths
attributed to the people aged 65 years and older by the end of 2021.\9\
One study looking at 4,254 LTC facilities across eight States found
that there were fewer COVID-19 cases in LTC facilities with four or
five stars for nurse staffing in the Five Star Quality Rating System
than in counterpart facilities with one to three stars for
staffing.\10\ These findings suggest that LTC facilities with low nurse
staffing levels may have been more susceptible to the spread of the
COVID-19 infection. Findings from a recent 2020 study involving all 215
nursing homes in Connecticut revealed that a 20-minute increase in RN
time spent providing direct care to residents was associated with 22
percent fewer confirmed cases of COVID-19 and 26 percent fewer COVID-19
related deaths.\11\ These findings suggest that there is a positive
relationship between the hours of direct care that RNs provide and
infection transmission in LTC facilities.
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\9\ March 2022 Report to the Congress: Medicare Payment Policy,
MEDPAC.
\10\ Figueroa JF, Wadhera RK, Papanicolas I, et al. Association
of Nursing Home Ratings on Health Inspections, Quality of Care, and
Nurse Staffing With COVID-19 Cases. JAMA. 2020;324(11):1103-1105.
doi:10.1001/jama.2020.14709.
\11\ <a href="https://agsjournals.onlinelibrary.wiley.com/doi/epdf/10.1111/jgs.16689">https://agsjournals.onlinelibrary.wiley.com/doi/epdf/10.1111/jgs.16689</a>.
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Workforce challenges have contributed to understaffing and nurse
burnout. The lack of adequate staffing impedes staff members' ability
to devote adequate time and attention to each resident. One study
looked at the impact of nurse burnout on organization and position
turnover. Findings indicated that 54 percent of the nurses sampled
suffered from moderate burnout and the impact of burnout on
organizational turnover was significant.\12\ While workforce challenges
have existed for years, and have many contributing factors, interested
parties have reported that the COVID-19 PHE exacerbated the problem as
many long-term care facilities experienced high worker turnover.
Potential factors contributing to this turnover include higher rates of
worker reported-stress; an inability of some workers to return to their
positions held prior to the pandemic (for instance, due to difficulty
accessing child care or concerns about contracting the COVID-19
infection for people with higher risk of severe illness); high rates of
mortality among long-term- care workers; and lower pay and job quality
in long-term care settings relative to others, such as more competitive
wage increases in retail and other industry jobs that tend to draw from
the same pool of workers.13 14 15 Although the COVID-19 PHE
has officially ended, the long-term care nursing workforce has been
slower to recover than the nursing workforce in other healthcare
settings, although it has steadily increased over the past year and a
half.16 17 Demand for direct care workers is also expected
to continue rising due to the growing needs of the aging
population.18 19
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\12\ Kelly LA, Gee PM, Butler RJ. Impact of nurse burnout on
organizational and position turnover. Nurs Outlook. 2021 Jan-
Feb;69(1):96-102. doi: 10.1016/j.outlook.2020.06.008. Epub 2020 Oct
4. PMID: 33023759; PMCID: PMC7532952.
\13\ Campbell, S., A. Del Rio Drake, R. Espinoza, K. Scales.
2021. Caring for the future: The power and potential of America's
direct care workforce. Bronx, NY: PHI. Accessed at <a href="http://phinational.org/wp-content/uploads/2021/01/Caring-for-the-Future-2021-PHI.pdf">http://phinational.org/wp-content/uploads/2021/01/Caring-for-the-Future-2021-PHI.pdf</a>.
\14\ Gasdaska, A., Segelman, M., Porter, K.A., Huber, B., Feng,
Z., Barch, D., Squillace, M., Dey, J., & Oliveira, I. Nursing Home
Staffing Disparities were Exacerbated during the COVID-19 Pandemic
in 2020 (Research Brief). Washington, DC: Office of the Assistant
Secretary for Planning and Evaluation, U.S. Department of Health and
Human Services. September 12, 2022. Accessed at <a href="https://aspe.hhs.gov/sites/default/files/documents/e37945b7d88efb005839a876660a59fb/nh-staffing-disparities-brief.pdf">https://aspe.hhs.gov/sites/default/files/documents/e37945b7d88efb005839a876660a59fb/nh-staffing-disparities-brief.pdf</a>.
\15\ Ochieng, N., Chidambaram, P., Musumeci, M. Nursing Facility
Staffing Shortages During the COVID-19 Pandemic. Apr 04, 2022.
Kaiser Family Foundation. Accessed at <a href="https://www.kff.org/coronavirus-covid-19/issue-brief/nursing-facility-staffing-shortages-during-the-covid-19-pandemic/">https://www.kff.org/coronavirus-covid-19/issue-brief/nursing-facility-staffing-shortages-during-the-covid-19-pandemic/</a>.
\16\ Refer, for example, to a report from the Kaiser Family
Foundation indicating that as of March 20, 2022, 28% of nursing
facilities reported a staffing shortage, as reported in Ochieng, N.,
Chidambaram, P., Musumeci, M. Nursing Facility Staffing Shortages
During the COVID-19 Pandemic. Apr 04, 2022. Kaiser Family
Foundation. Accessed at <a href="https://www.kff.org/coronavirus-covid-19/issue-brief/nursing-facility-staffing-shortages-during-the-covid-19-pandemic">https://www.kff.org/coronavirus-covid-19/issue-brief/nursing-facility-staffing-shortages-during-the-covid-19-pandemic</a>.
\17\ <a href="https://data.bls.gov/timeseries/CES6562300001?amp%253bdata_tool=XGtable&output_view=data&include_graphs=true">https://data.bls.gov/timeseries/CES6562300001?amp%253bdata_tool=XGtable&output_view=data&include_graphs=true</a>.
\18\ Campbell, S., A. Del Rio Drake, R. Espinoza, K. Scales.
2021. Caring for the future: The power and potential of America's
direct care workforce. Bronx, NY: PHI <a href="http://phinational.org/wp-content/uploads/2021/01/Caring-for-the-Future-2021-PHI.pdf">http://phinational.org/wp-content/uploads/2021/01/Caring-for-the-Future-2021-PHI.pdf</a>.
\19\ Centers for Medicare & Medicaid Services. November 2020.
Long-Term Services and Supports Rebalancing Toolkit. Accessed at
<a href="https://www.medicaid.gov/medicaid/long-term-services-supports/downloads/ltss-rebalancing-toolkit.pdf">https://www.medicaid.gov/medicaid/long-term-services-supports/downloads/ltss-rebalancing-toolkit.pdf</a>.
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The studies discussed in this section, corroborated by public
comment submissions, input provided through listening sessions, and the
2022 Nursing Home Staffing Study, demonstrate the consequences of
understaffing on resident health and safety. Yet, ongoing insufficient
staffing as well as the widespread variability in existing minimum
staffing standards across the United States (for example, 38 States and
the District of Columbia have minimum nursing staffing standards;
however, there are significant variations in their requirements)
highlights the need for national minimum staffing standards for direct
care in LTC facilities.
Chronic understaffing continues in LTC facilities, and evidence
demonstrates the benefits of increased nurse staffing in these
facilities. For example, a report by the Office of the Inspector
General (OIG) highlighted that in 2018, roughly 7 percent of nursing
homes failed to provide 8 hours per day of RN staffing on at least 30
total days during the year.\20\ Some studies have demonstrated that
increased staffing levels were specifically beneficial to vulnerable
subpopulations in nursing homes, such as residents with dementia or
Alzheimer's disease. One cross sectional study of long-stay residents
with Alzheimer's disease and related dementias found that residents in

[[Page 61357]]

nursing homes that had higher licensed nurse staffing levels had better
end-of-life care and were less likely to experience potentially
avoidable hospitalizations.\21\ Yet, the literature evidence suggests
that staffing levels within facilities across the United States vary
considerably, with less staffed facilities more likely to be for--
profit, larger, rural, and have a higher share of Medicaid residents.
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\20\ Office of Inspector General (OIG), Some Nursing Homes'
Reported Staffing Levels in 2018 Raise Concerns; Consumer
Transparency Could Be Increased, OEI-04-18-00451, August 2020.
<a href="https://oig.hhs.gov/oei/reports/oei-04-18-00450.asp">https://oig.hhs.gov/oei/reports/oei-04-18-00450.asp</a>.
\21\ Jessica Orth, Yue Li, Adam Simning, Sheryl Zimmerman,
Helena Temkin-Greener, End-of-Life Care among Nursing Home Residents
with Dementia Varies by Nursing Home and Market Characteristics
Journal of the American Medical Directors Association, Volume 22,
Issue 2, 2021, Pages 320-328.e4, ISSN 1525-8610, <a href="https://doi.org/10.1016/j.jamda.2020.06.021">https://doi.org/10.1016/j.jamda.2020.06.021</a>.
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Finally, multiple studies have shown that nursing home quality is
generally lower in LTC facilities that serve high proportions of
minority residents.22 23 24 Facilities that have a higher
proportion of minority residents tend to have limited clinical and
financial resources, low nurse staffing levels, and a high number of
care deficiency citations.25 26 Furthermore, disparities in
safety and quality care exist between LTC facilities with a high number
of Medicaid residents and LTC facilities that have a high number of
Medicare residents.\27\ These disparities can contribute to differences
in quality across facilities' sites.\28\
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\22\ <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3805666/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3805666/</a>.
\23\ <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4108174/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4108174/</a>.
\24\ <a href="https://onlinelibrary.wiley.com/doi/epdf/10.1111/1475-6773.12079">https://onlinelibrary.wiley.com/doi/epdf/10.1111/1475-6773.12079</a>.
\25\ <a href="https://www.jamda.com/article/S1525-8610">https://www.jamda.com/article/S1525-8610</a>(21)00243-7/
fulltext.
\26\ <a href="https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2015.0094">https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2015.0094</a>.
\27\ Mor, Vincent et al. ``Driven to tiers: socioeconomic and
racial disparities in the quality of nursing home care.'' The
Milbank quarterly vol. 82,2 (2004): 227-56. doi:10.1111/j.0887-
378X.2004.00309.x.
\28\ <a href="https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2015.0094">https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2015.0094</a>.
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As such, we believe that national minimum staffing standards in LTC
facilities and the adoption of a 24/7 RN and enhanced facility
assessment requirements (as discussed later in this proposed rule),
will help to advance equitable, safe, and quality care for all
residents. Specifically, we propose individual minimum nurse staffing
standards of 0.55 hours per resident day (HPRD) for RNs and 2.45 HPRD
for NAs, that were developed using case-mix adjusted data sources.
There were several considerations that helped us arrive at these
proposed standards (discussed in detail later in this proposed rule).
First, the evidence and findings from the 2022 Nursing Home Staffing
Study demonstrated that there was a statistically significant
difference in safety and quality care at 0.45 HPRD for RNs and higher
including 0.55 HPRD; there was a statistically significant difference
in safety and quality care at 2.45 HPRD and higher for NAs. Second, we
evaluated existing State requirements and note that the proposed RN
requirement of 0.55 HPRD is higher than every State and only lower than
the District of Columbia (DC) based on September 2022 data. Third, we
aimed to strike an appropriate balance between cost and benefit that
would yield the strongest improvements in quality and safety for
residents. We are not proposing minimum staffing standards based on
HPRD for licensed nurses, that is, RNs plus LPN/LVNs, nor for total
nurse staffing, that is, RNs, LPN/LVNs, and NAs because of evidence in
the literature described below.
This proposed policy is based on statistical evidence from clinical
settings which suggests that more positive clinical outcomes are
associated with increasing the number of RNs and NAs. We are not
setting a minimum staffing standard for LPN/LVNs. In addition, as noted
in the next section, it has been reported in the literature that LPN/
LVNs may find themselves practicing outside their scope of practice
when there is not sufficient RN staffing in a facility to provide
supervision. This is concerning because LPN/LVNs require an RN or a
physician's supervision to practice. Furthermore, total licensed nurse
staffing standards may ensure adequate levels of licensed nurse
staffing and allow nursing homes the flexibility to substitute nurse
type for example LPN/LVNs for RNs, or NAs for LPN/LVNs, but may result
in compromising the safety and quality of care. Multiple studies have
found no evidence of a consistent relationship of quality and safety
with LPN staffing.\29\ First, literature evidence suggests that there
is a negative correlation between LPN and RN staffing, indicating that
nursing homes with higher LPN staffing levels tend to have lower RN
staffing levels.\30\ Second, the 2022 Nursing Home Staffing Study did
not demonstrate an association between LPN/LVNs' HPRD, at any level,
and safe and quality care.\31\
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\29\ Abt Associates. (2022). Nursing Home Staffing Study
Comprehensive report. Report prepared for the Centers for Medicare &
Medicaid Services. <a href="https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf">https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf</a>.
\30\ Abt Associates. (2022). Nursing Home Staffing Study
Comprehensive report. Report prepared for the Centers for Medicare &
Medicaid Services. <a href="https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf">https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf</a>.
\31\ Abt Associates. (2022). Nursing Home Staffing Study
Comprehensive report. Report prepared for the Centers for Medicare &
Medicaid Services. <a href="https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf">https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf</a>.
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Many studies indicate that consistent, adequate nurse staffing is
correlated with resident health and safety, but we seek additional
information to make fully informed policy decisions. We welcome input
from interested parties on the considerations and proposals discussed
in this rule, and other comments that may be relevant. We encourage
commenters to submit evidence and data to support any recommendations
to the extent possible. We continue to seek additional information that
supports our efforts for improving the safety and quality of care for
residents within LTC facilities, including feedback on how to improve
care transitions and discharge planning, such as information about and
assistance with programs that assist with community placements.
We are soliciting comments and recommendations in this area and
have also included specific information requests that are embedded
throughout this rule regarding certain proposals. We seek this
information in anticipation that additional comments and
recommendations will assist us in ensuring that we finalize appropriate
minimum staffing standards to ensure the health and safety of residents
and provide staff the support they need to care for residents while
also considering the limited resources including the local supply of
RNs and NAs, that may exist as the long-term care sector recovers from
the COVID-19 PHE and an increased demand due to a growing older
population.
3. CMS Actions and Key Considerations To Inform Mandatory Minimum
Staffing Standards
In February 2022, President Biden announced a comprehensive set of
reforms aimed at improving the safety and quality of care within the
nation's nursing homes. One key initiative within the Biden-Harris
Administration's strategy is to establish a minimum nursing home
staffing requirement for LTC facilities participating in Medicare and
Medicaid.\32\ Establishing minimum staffing standards improves the
likelihood that all nursing home residents are provided safe, high-
quality

[[Page 61358]]

care, and that workers have the support they need to provide high-
quality care.
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\32\ <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2022/02/28/fact-sheet-protecting-seniors-and-people-with-disabilities-by-improving-safety-and-quality-of-care-in-the-nations-nursing-homes/">https://www.whitehouse.gov/briefing-room/statements-releases/2022/02/28/fact-sheet-protecting-seniors-and-people-with-disabilities-by-improving-safety-and-quality-of-care-in-the-nations-nursing-homes/</a>.
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To help inform our efforts in establishing consistent and broadly
applicable national minimum staffing standards, we launched a multi-
faceted approach aimed at determining the minimum level and type of
staffing needed to enable safe and quality care in LTC facilities. This
effort included issuing the FY2023 SNF PPS RFI,\33\ hosting listening
sessions with various interested parties, and conducting a 2022 Nursing
Home Staffing Study, which builds on existing evidence and several
research studies using multiple data sources. In addition to launching
our multi-faceted approach, we considered how any potential minimum
staffing standards affect other CMS programs and/or initiatives as well
as the enforceability of such standards. Our strategic approach and
considerations are discussed later in this section.
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\33\ Medicare Program; Prospective Payment System and
Consolidated Billing for Skilled Nursing Facilities; Updates to the
Quality Reporting Program and Value-Based Purchasing Program for
Federal Fiscal Year 2023; Request for Information on Revising the
Requirements for Long-Term Care Facilities To Establish Mandatory
Minimum Staffing Levels. A Proposed Rule by the Centers for Medicare
& Medicaid Services on 04/15/2022 <a href="https://www.federalregister.gov/documents/2022/04/15/2022-07906/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities">https://www.federalregister.gov/documents/2022/04/15/2022-07906/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities</a>.
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a. Request for Information in the FY 2023 Skilled Nursing Facility
Prospective Payment System Proposed Rule (FY 2023 SNF PPS RFI)
We published the FY 2023 SNF PPS RFI in April 2022, soliciting
public comments on minimum staffing standards. In response to the FY
2023 SNF PPS RFI, we received over 3,000 comments from a variety of
parties interested in addressing LTC facilities' issues including
advocacy groups, long-term care ombudsmen, industry associations
(providers), labor unions and organizations, nursing home residents,
staff and administrators, industry experts, researchers, family
members, and caregivers of residents in LTC facilities.
Notably, industry associations and resident advocates expressed
divergent views on the establishment of minimum staffing standards.
Resident advocacy groups and family members of residents were strongly
supportive of establishing minimum staffing standards, while industry
and provider groups expressed significant concern and opposition to
such standards.
Commenters supporting the establishment of minimum staffing
standards voiced safety concerns regarding residents not receiving
adequate care due to chronic understaffing in facilities. For example,
residents going entire shifts without receiving toileting assistance,
which can lead to an increase in falls or the development or worsening
of pressure ulcers. Commenters noted that NAs barely have time to get
each resident dressed, fed, and bathed; that residents lie for hours in
wet and soiled diapers; that residents who need help to eat struggle to
feed themselves; and that residents suffer abuse from staff and other
residents because no one is watching. Commenters also shared stories of
residents wearing the same outfit for a week without a change of
clothing or a shower. Commenters highlighted the contribution of
facility staff and attributed the lack of quality care to insufficient
staffing levels.
Commenters also offered recommendations for implementing minimum
staffing standards including staffing with a RN on every shift. Some
commenters suggested that CMS focus on implementing an acuity (that is,
the medical complexity and needs of a resident) staffing model per
shift as part of any minimum staffing standards. Others recommended
that minimum staffing standards be established for residents with the
lowest care needs, assessed using the Minimum Data Set (MDS) 3.0
assessment forms, citing concerns that acuity-based minimum standards
will be more susceptible to gaming around composition of the patient
population (that is, avoiding taking on residents with more complex
medical needs).
Concerns raised by the local ombudsmen in the 2020 OIG Report on
staffing levels echoed those raised by commenters. Some of the concerns
identified in the OIG Report as a result of understaffing include
residents' call lights going unanswered, medication errors, untreated
wounds, and inadequate bathing, including residents going a week
without a shower. The ombudsmen also focused on problems related to
weekend staffing below required levels, resulting in resident falls and
altercations between residents; the ombudsmen attributed such outcomes
to facilities' inadequate leadership, as well as insufficient numbers
of NAs.\34\ This information supports what was shared with us during
the listening sessions as well as during the public comment period on
the FY 2023 SNF PPS RFI.
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\34\ Office of Inspector General Data Brief (August, 2020) Some
Nursing Homes' Reported Staffing Levels in 2018 Raise Concerns;
Consumer Transparency Could Be Increased. OEI-04-18-00450. <a href="https://oig.hhs.gov/oei/reports/OEI-04-18-00450.pdf">https://oig.hhs.gov/oei/reports/OEI-04-18-00450.pdf</a>.
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Commenters also provided information on several resident and
facility factors for consideration when assessing a facility's ability
to meet any mandated staffing standards, including whether the facility
has a high Medicaid census, high bed count, for-profit ownership, high
SNF competition within the same county, high community poverty rates,
low Medicare census, and for staffing, availability of RNs
specifically. Other commenters stated that resident acuity should be a
primary determinant in establishing minimum staffing standards, noting
that CMS pays nursing homes based on resident acuity level.
We also received comments on factors impacting facilities' ability
to recruit and retain staff, with most commenters in support of
creating avenues for competitive wages for nursing home staff to
address issues of recruitment and retention. Other commenters, however,
suggested that year-over-year reductions in skilled nursing facility
payments complicate facilities' ability to increase staff wages and
benefits.
Finally, we received differing comments on the study design,
payment, and cost impacts of establishing minimum staffing standards.
Some commenters indicated that there is variability in Medicaid labor
reimbursement amounts and many States' Medicaid rates do not keep up
with rising labor costs. Others, however, noted that most facilities
have adequate resources to increase their staffing levels without
additional Medicaid resources, and cited a recent study that suggests
that most major publicly traded nursing home companies were highly
profitable, even during the COVID-19 PHE. Commenters provided robust
feedback on the study design and method for implementing nurse staffing
standards, while others noted that resident acuity could change on a
daily basis and recommended that CMS establish benchmarks rather than
absolute values in staffing standards. Other commenters recommended
using both minimum nurse HPRD and nurse to resident ratios.
Additionally, we note that several members of Congress have
provided input regarding the establishment of minimum staffing
standards. While some Members of Congress have expressed concern that
requiring minimum staffing standards could create access issues for
rural communities, other Members of Congress have expressed support for
establishing minimum staffing

[[Page 61359]]

standards for LTC facilities.\35\ We appreciate the thoughtful feedback
from commenters and have considered the varying feedback that we
received to inform the staffing study design and proposal for minimum
staffing standards discussed in this rule.
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\35\ Sen Tester, Nursing Home Staffing Mandate, 2023; <a href="https://www.tester.senate.gov/wp-content/uploads/1-20-23-Nursing-Home-Staffing-Mandate-Letter-FINAL.pdf">https://www.tester.senate.gov/wp-content/uploads/1-20-23-Nursing-Home-Staffing-Mandate-Letter-FINAL.pdf</a>; Sen Casey, Wyden, et al, Nursing
Home Staffing Mandate, 2023; <a href="https://www.aging.senate.gov/imo/media/doc/letter_to_cms_re_regulations_to_establish_minimum_staffing_levels_in_nursing_homes.pdf">https://www.aging.senate.gov/imo/media/doc/letter_to_cms_re_regulations_to_establish_minimum_staffing_levels_in_nursing_homes.pdf</a>; Doggett, Schakowsky Lead Effort Pressing for
Strong Nursing Home Staffing Standards [verbar] Congressman Lloyd
Doggett (<a href="http://house.gov">house.gov</a>), <a href="https://doggett.house.gov/media/press-releases/doggett-schakowsky-lead-effort-pressing-strong-nursing-home-staffing-standards">https://doggett.house.gov/media/press-releases/doggett-schakowsky-lead-effort-pressing-strong-nursing-home-staffing-standards</a>.
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b. The 2022 Nursing Home Staffing Study \36\
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\36\ Abt Associates. (2022). Nursing Home Staffing Study
Comprehensive report. Report prepared for the Centers for Medicare &
Medicaid Services. <a href="https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf">https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf</a>.
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The CMS commissioned a nursing home staffing study in 2001,
entitled ``Appropriateness of Minimum Nurse Staffing Ratios in Nursing
Homes'',\37\ commonly referred to as the 2001 CMS Staffing Study, that
focused on two empirical analyses related to the link between staffing
and quality: (1) whether there is a nurse staffing ratio above which no
additional improvements in quality are observed, and (2) what nurse
staffing thresholds are minimally necessary to provide care processes
consistent with the Omnibus Budget Reconciliation Act (OBRA) of 1987
optimal standards and related regulations.
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\37\ Appropriateness of Minimum Nurse Staffing Ratios in Nursing
Homes (2001) <a href="https://www.justice.gov/sites/default/files/elderjustice/legacy/2015/07/12/Appropriateness_of_Minimum_Nurse_Staffing_Ratios_in_Nursing_Homes.pdf">https://www.justice.gov/sites/default/files/elderjustice/legacy/2015/07/12/Appropriateness_of_Minimum_Nurse_Staffing_Ratios_in_Nursing_Homes.pdf</a>
.
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The study findings identified nursing home staffing thresholds
beyond which additional staff did not lead to significant further
improvements in care. These staffing levels, expressed in HPRD, varied
by outcomes--short-stay or -long-stay- quality measures, by nurse staff
type, and by level of nurse staffing. Depending on the nature of the
nursing home population (case-mix), these thresholds ranged between:
0.55 to 0.75 HPRD for RNs; 1.15 to 1.30 HPRD for licensed nurses (RNs
and LPN/LVNs); and 2.4 to 2.8 HPRD for NAs. The 2001 study also
reported that ``[m]inimum staffing levels at any level up to these
thresholds are associated with incremental quality improvements, with
the greatest benefits as these thresholds are approached.'' In other
words, 4.1 HPRD was the highest HPRD of combined NAs and licensed staff
(RNs/LPN/LVN) for long-stay measures beyond which no further
improvement in safety and quality was observed. The 4.1 HPRD drawn from
the 2001 Study is commonly misinterpreted as the minimum total nurse
staffing that is needed to protect resident health and safety.
The CMS also commissioned a simulation analysis (``time motion
study'') on NA time expended for providing five key care processes,\38\
in addition to routine care, to determine an HPRD level for NAs to
provide optimal nursing care. The study findings suggest that the NA
HPRD level ranged between 2.8 (low workload facility) and 3.2 HPRD
(high workload facility) for NAs only, depending on the NA workload
requirements which was based on the nursing home resident population.
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\38\ Five care processes were the following: (1) dressing/
grooming; (2) exercise; (3) feeding assistance; (4) changing and
repositioning; and (5) providing toileting assistance.
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Given the growing body of evidence demonstrating the importance of
staffing to resident health and safety, the continued insufficient
staffing, and variability in nurse-to-resident ratios across States,
creating a consistent floor will reduce the risk of residents receiving
unsafe and low-quality care. In 2022, given the age of the 2001 study
and the persistent chronic nurse understaffing linked to poor safety
and quality care, which was exacerbated by the COVID-19 PHE, we
commissioned a new nursing home study that focused on a non-empirical
analysis and four empirical analyses to develop minimum staffing
standards using case-mix adjusted data sources, as well as staffing
types and levels for improving safety and quality care in nursing
homes.
These non-empirical and empirical analyses, also known as study
tasks, included a systematic literature review, qualitative analysis of
data collected using interviews and surveys conducted during scheduled
site visits, an observation study (``similar to the time motion
study'') followed by simulation modeling analysis for licensed nurses
(RNs and LPN/LVNs), quantitative analyses which included descriptive
and impact analyses, and cost analyses. The key takeaways from the
multifaceted approach are:
<bullet> Recent literature as well as testimonials from nursing
home staff, residents, and family members underscore the relationship
between staffing and care quality; however, there is no clear,
consistent, and universal methodology for setting specific minimum
staffing standards, as evidenced by the varying current standards
across certain States.
<bullet> Nurse staffing levels vary considerably nationwide by LTC
facilities' characteristics, such as location, size, and profit status
and States. Thirty-eight States and the District of Columbia have
minimum staffing standards, which vary considerably. We note that the
proposed RN requirement of 0.55 HPRD is higher than every State, and
only lower than the District of Columbia (DC) based on data from
September 2022. Our proposed NA requirement of 2.45 HPRD is higher than
all States and DC, based on data reported in September
2022.36 39 To reiterate, LTC facilities would be required to
meet both the proposed 0.55 HPRD for RNs and the 2.45 HPRD for NAs.
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\36\ Payment and Access Commission (MACPAC). (2022a). Medicaid
and CHIP Payment and Access Commission (MACPAC). (2022a).
Compendium: State policies related to nursing facility staffing.
<a href="https://www.macpac.gov/publication/statepolicies-related-tonursing-facility-staffing/">https://www.macpac.gov/publication/statepolicies-related-tonursing-facility-staffing/</a>.
\39\ Consumer Voice (The National Consumer Voice for Quality
Long-Term Care) (2021). State nursing home staffing standards:
Summary report <a href="https://theconsumervoice.org/issues/otherissues-andresources/staffing">https://theconsumervoice.org/issues/otherissues-andresources/staffing</a>.
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<bullet> The relationship between staffing and quality of care and
safety, varies by staff type and level as follows:
++ RN hours per resident day of 0.45 or more have a strong
association with safety and quality care.
++ NA hours per resident day of 2.45 or more also have a strong
association with safety and quality care.
++ LPN/LVN hours per resident day, at any level, do not have any
association with safety and quality of care.40 41 42
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\40\ Akinci, Fevzi, and Diane Krolikowski. ``Nurse staffing
levels and quality of care in Northeastern Pennsylvania nursing
homes.'' Applied nursing research: ANR vol. 18,3 (2005): 130-7.
doi:10.1016/j.apnr.2004.08.004.
\41\ Yang, Bo Kyum et al. ``Nurse Staffing and Skill Mix
Patterns in Relation to Resident Care Outcomes in US Nursing
Homes.'' Journal of the American Medical Directors Association vol.
22,5 (2021): 1081-1087.e1. doi:10.1016/j.jamda.2020.09.009.
\42\ Spilsbury, Karen et al. ``The relationship between Nurse
staffing and quality of care in nursing homes: a systematic
review.'' International journal of nursing studies vol. 48,6 (2011):
732-50. doi:10.1016/j.ijnurstu.2011.02.014.
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<bullet> Increasing nursing staffing level is associated with
costs, namely financial costs to LTC facilities, as well as benefits,
including enhanced safety and quality to varying degrees.
In brief, the 2022 Nursing Home Staffing Study was conducted as a
general framework to survey different sources of information and to
conduct different types of analyses to help inform the minimum staffing
decision process, while considering the potential

[[Page 61360]]

cost and benefit. The study \43\ was unable to examine the relationship
between staffing levels by shift and quality/patient safety because the
PBJ System does not include information on staffing by shift. In
addition, there was limited information on non-nurse staffing, so the
study team was unable to examine minimum staffing standards for non-
nurse staff.
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\43\ Abt Associates. (2022). Nursing Home Staffing Study
Comprehensive report. Report prepared for the Centers for Medicare &
Medicaid Services. <a href="https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf">https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf</a>.
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Unlike the 2001 CMS Staffing Study, the 2022 Nursing Home Staffing
Study was guided by a conceptual model (see Figure 1), that
hypothesizes that administrative practices (for example, nurse staffing
levels, staffing mix, care delivery model, and organizational
environment) influence the quality and safety of care provided in a
nursing home, which, in turn, influences nursing home residents'
outcomes (that is, clinical, safety, and disparity). Clinical outcomes
were defined using Care Compare quality measures derived from the MDS
and Medicare claims data. Patient safety was defined using measures
from health inspection surveys.
[GRAPHIC] [TIFF OMITTED] TP06SE23.000

(1) Systematic Literature Review
The overall goal of the systematic literature review was to
summarize timely and current evidence of the relationship between
minimum staffing standards in nursing homes and the safety and quality
of care, as well as clarify the relative strengths and weaknesses of
the available literature. In addition, the systematic literature review
of existing peer-reviewed and ``gray literature'' (that is, published
outside the traditional research publications such as opinion pieces,
advocacy materials, and non-statistically rigorous research published
by government agencies) which includes printed articles, for the
initial period 2019-2022, and prior to 2019 if needed, focused on
addressing the following questions:
<bullet> What is the relationship between nurse staffing levels and
safety and quality of care? What minimum staffing levels associated
with safety and quality of care have been identified in previous
studies, and what is the empirical basis for them?
<bullet> What are the current State and Federal standards for
staffing level/types and outcomes in nursing homes for weekdays,
weekends, and evenings?
<bullet> What is the role of different nurse types (that is, RNs/
LPN/LVNs/NAs) in ensuring safety and quality of nursing home care?
<bullet> What are the costs associated with nurse staffing in
nursing homes? What are the costs associated with implementing minimum
nurse staffing standards and increasing nurse staffing levels/types?
Most importantly, an increase in nurse staffing was associated with
improved quality of care. In a 2021 study, where interview data were
examined, and multivariate analyses of resident outcomes were
conducted, authors concluded that higher total nurse staffing had a
significant correlation with a decreased number of pressure ulcers, an
increase in influenza vaccination, an increase in pneumonia
vaccination, and decreased number of

[[Page 61361]]

outpatient emergency department visits.\44\
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\44\ Wagner, L.M., Katz, P., Karuza, J., Kwong, C., Sharp, L., &
Spetz, J. (2021). Medical staffing organization and quality of care
outcomes in post- acute care settings. Gerontologist, 61(4),605-614.
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However, the OBRA of 1987,\45\ which amended sections 1819 and 1919
of the Act to mandate staffing standards in nursing homes, did not
mandate specific numerical minimum nurse staffing standards. As such
several States mandated variable staffing standards to help meet the
standards in sections 1819 and 1919 of the Act.
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\45\ chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/
<a href="https://static1.squarespace.com/static/602ac1a3ede5cc16ae72d619/t/6043c094b391303a2d1c1418/1615052948879/OBRA87summary.pdf">https://static1.squarespace.com/static/602ac1a3ede5cc16ae72d619/t/6043c094b391303a2d1c1418/1615052948879/OBRA87summary.pdf</a>.
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As stated in the 2022 Nursing Home Staffing Study report,\46\ which
will be published concurrently with this proposed rule, studies found
that States that established higher nurse staffing standards resulted
in increased staffing within nursing homes, but the magnitude of this
increase varied by the staff type. For example, authors found that when
the States of California and Ohio required increased licensed nurse or
total nurse staffing standards, this resulted in some actual increase
in staffing levels. California required facilities to increase the
hours for direct resident care per day from 3.0 to 3.2 and prohibited
the previous practice of allowing RN or LPN hours to be counted twice,
also known as ``doubling''. The rationale for doubling was to increase
the number of licensed staff. Ohio law required facilities to increase
total nurse staffing (RN, LPN/LVN, and NA) direct care hours from 1.6
to 2.75. Results showed that for both California and Ohio, nursing
homes that ranked in the bottom quartile at baseline on total nurse
staffing significantly increased their HPRDs for all three types of
nursing staff (RN, LPN/LVN, and NA). However, there was a reduction in
professional skill mix, meaning there were fewer RNs relative to other
direct care staff, 71 percent of the increase in nursing staff
represented an increase in NA hours.\47\
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\46\ Abt Associates. (2022). Nursing Home Staffing Study
Comprehensive report. Report prepared for the Centers for Medicare &
Medicaid Services. <a href="https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf">https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf</a>.
\47\ Chen, Min M, and David C Grabowski. ``Intended and
unintended consequences of minimum staffing standards for nursing
homes.'' Health economics vol. 24,7 (2015): 822-39. doi:10.1002/
hec.3063.
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Another study, when controlling for changes in State minimum direct
care staffing standards during the study period, in Arkansas, Delaware,
Florida, and Ohio, found that nursing homes serving a higher share of
Medicaid patients reported large increases in staffing, specifically
RNs, in response to a one HPRD increase in total nurse staffing from a
baseline of 2.0 HPRD requirement for total nurse staffing.\48\ In sum,
studies found that nursing homes in States with higher minimum staffing
standards employed more staff.
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\48\ Bowblis, John R. ``Staffing ratios and quality: an analysis
of minimum direct care staffing requirements for nursing homes.''
Health services research vol. 46,5 (2011): 1495-516. doi:10.1111/
j.1475-6773.2011.01274.x.
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Most LTC facilities typically have nurse teams providing care to
residents with very few RNs (8 percent) making up the team, compared to
other nurse team members, (that is, administrative RNs, LPN/LVNs and
unlicensed assisting staff)49 50 which suggests that LPN/
LVNs provide most of the clinical care with minimal supervision from
RNs.\51\ Other study findings suggest that some Directors of nursing
(DONs) view the roles of RNs and LPN/LVNs interchangeably despite the
difference in educational preparation and scope of practice. Yet, study
findings suggest that having more RNs in LTC facilities to provide
clinical skills and supervision of LPNs positively influences LPNs
contributions to improved quality care.\52\ In summary, the presence of
more RNs on a team influences the quality of care provided.
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\49\ American Health Care Association (2012) LTC stats: Nursing
facility operational characteristics report. Retrieved from <a href="http://www.ahcancal.org/research_data/oscar_data/Nursing%20Faciliry%20Operational%Characteristics/LTC+STATS_PVNFOPERATIONS_2012Q4_FINAL.pdf">http://www.ahcancal.org/research_data/oscar_data/Nursing%20Faciliry%20Operational%Characteristics/LTC+STATS_PVNFOPERATIONS_2012Q4_FINAL.pdf</a>.
\50\ Siegel, Elena O et al. ``Leadership in Nursing Homes:
Directors of Nursing Aligning Practice With Regulations.'' Journal
of gerontological nursing vol. 44,6 (2018): 10-14. doi:10.3928/
00989134-20180322-03.
\51\ Corazzini, Kirsten N et al. ``Licensed practical nurse
scope of practice and quality of nursing home care.'' Nursing
research vol. 62,5 (2013): 315-24. doi:10.1097/NNR.0b013e31829eba00.
\52\ Corazzini, Kirsten N et al. ``Licensed practical nurse
scope of practice and quality of nursing home care.'' Nursing
research vol. 62,5 (2013): 315-24. doi:10.1097/NNR.0b013e31829eba00.
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Based on gray literature, a coalition of resident nursing home
advocates and the National Academies of Sciences, Engineering, and
Medicine recommended RN coverage, with at least one RN, for 24 hours a
day, 7 days a week, with additional RN coverage if needed, as part of
the minimum staffing standards.53 54
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\53\ California Advocates for Nursing Home Reform, Center for
Medicare Advocacy, Justice in Aging, Long Term Care Community
Coalition, Michigan Elder Justice Initiative, and The National
Consumer Voice for Quality Long-Term Care. (2021). Framework. for
nursing home reform post COVID-19. <a href="https://theconsumervoice.org/uploads/files/actionsand-newsupdates/Framework_and_overview_FINAL.pdf">https://theconsumervoice.org/uploads/files/actionsand-newsupdates/Framework_and_overview_FINAL.pdf</a>.
\54\ National Academies of Sciences, Engineering, and
Medicine.(2022).The national imperative to improve nursing home
quality: Honoring our commitment to residents, families, and staff.
The National Academies Press. <a href="https://doi.org/10.17226/26526">https://doi.org/10.17226/26526</a>.
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Several costs for increasing nurse staffing were cited in the
literature, we note that these costs differ from our estimated costs as
set out in this proposed rule. For example, in one study, by trade
groups representing the industry, 4.1 HPRD for total nurse staffing
(that is, RNs, LPN/LVNs and NAs) was found to cost the long-term care
industry more than $10 billion annually.\55\ Another study estimated
that the additional staffing costs to meet the 4.1 HPRD for total nurse
staffing as $7.25 billion.\56\ In summary, several studies found that
higher levels of nurse staffing, including RNs, were associated with
improved resident care outcomes and increased costs.
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\55\ CLA (CliftonLarsonAllen, LLC). (2022). Staffing mandate
analysis. In-depth analysis on minimum nurse staffing levels and
local impact. American Health Care Association and the National
Center for Assisted Living (AHCA/NCAL). <a href="https://www.ahcancal.org/News-and-Communications/Fact-Sheets/FactSheets/CLA-Staffing-Mandate-Analysis.pdf">https://www.ahcancal.org/News-and-Communications/Fact-Sheets/FactSheets/CLA-Staffing-Mandate-Analysis.pdf</a>.
\56\ Hawk, T., White, E.M., Bishnoi, C., Schwartz, L.B., Baier,
R.R., & Gifford, D. R. (2022). Facility characteristics and costs
associated with meeting proposed minimum staffing levels in skilled
nursing facilities. Journal of the American Geriatrics Society,
70(4), 1198-1207. <a href="https://doi.org/10.1111/jgs.17678">https://doi.org/10.1111/jgs.17678</a>.
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(2) Qualitative Analysis
Thirty-one nursing homes were selected for scheduled site visits in
14 States, specifically California, Colorado, Florida, Illinois,
Massachusetts, Maryland, Missouri, North Carolina, New York, Ohio,
Pennsylvania, Virginia, Washington, and Wyoming. These site visits
started in September 2022, and ended in December 2022. nursing homes
were selected to ensure a national representation by size, ownership
type, geographic location, Medicaid population, and overall rating
under the Five-Star Quality Rating System. Nursing homes voluntarily
participated in these site visits and no incentives were offered. Site
visit protocols and interview guides were reviewed and approved by Abt
Associates Inc. Institutional Review Board.\57\ Site visits were
conducted under the Nursing Home Reform Law in the Omnibus Budget
Reconciliation Act of 1987 (OBRA '87) (Pub. L. 100-203), which is
exempt from the Paperwork Reduction Act (PRA).
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\57\ <a href="https://abtimpact.com/mission-impact-2020/ethics-and-governance/">https://abtimpact.com/mission-impact-2020/ethics-and-governance/</a>.
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During site visits, interviews (n=361) were conducted with 76
nursing home leadership, 195 direct care staff

[[Page 61362]]

(including RNs, LPN/LVNs, and NAs), 65 residents, and 25 family members
to better understand the relationship between staffing levels, staffing
mix (what types of staff are present), and resident outcomes and
experiences (that is, clinical outcomes, safety, health disparities).
Staff completed 168 Missed Nursing Care (MISSCARE) \58\ surveys to
determine any omitted or delayed care.
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\58\ Kalish, B.J., & Williams, R.A. (2009). Development and
psychometric testing of a tool to measure missed nursing care. The
Journal of Nursing Administration, 39(5), 211-219. <a href="https://doi.org/10.1097/nna.0b013e3181a23cf5">https://doi.org/10.1097/nna.0b013e3181a23cf5</a>.
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Findings from data analyses of surveys and interviews highlighted
that activities of daily living care tasks, including bathing,
toileting, and mobility assistance, are the most frequently delayed
tasks when shifts/units are short staffed. Family members also reported
that quality of life, quality of care, and resident safety are
adversely affected when nursing homes are short staffed. Some staff
stated that rushing through care due to having high-acuity residents,
meaning that their condition is severe and imminently dangerous, or a
high number of assigned residents led to medication errors and safety
issues. For example, one nurse stated that being assigned 33 patients
without any other staff is not safe. Respondents also noted that
different staffing requirements for NAs and licensed nurses, among
other factors, should be considered when developing minimum staffing
standards. Nursing home staff respondents also suggested minimum staff-
to-resident ratios. NA respondents proposed a ratio of 5 to 14
residents per NA, whereas RNs and LPN/LVNs suggested ratios from 8 to
25 residents per licensed nurse (RN and LPN/LVNs). Respondents worked
across a variety of shifts, units, and resident types (for example,
skilled nursing/rehabilitation, long-term care, total care, dementia
care, and behavioral issues), so the acuity of residents they typically
supported varied as did the ratios they proposed.
(3) Observation Study/Simulation Modeling
Twenty LTC facilities were selected based on a convenience sampling
method for the observation study. Time data of 8,249 unique care tasks
were collected via direct observations of licensed nursing staff (that
is, RN and LPN/LVNs) providing common clinical tasks including
medication pass, resident assessment, wound care, and catheter/device
care. Previous simulation modeling research focused on NAs providing
non-clinical tasks specifically, activities of daily living (ADL)
tasks,\59\ but not on clinical tasks. Thus, this simulation study was
aimed at addressing this gap in knowledge and focused exclusively on
specific clinical tasks provided by licensed nurses.
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\59\ Schnelle, J.F., Schroyer, L.D., Saraf, A.A., & Simmons,
S.F. (2016). Determining nurse aide staffing requirements to provide
care based on resident workload: A discrete event simulation model.
Journal of the American Medical Directors Association, 17(11), 970-
977. <a href="https://doi.org/10.1016/j.jamda.2016.08.006">https://doi.org/10.1016/j.jamda.2016.08.006</a>.
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These data were used to develop a simulation model to examine the
impact of different levels of licensed nurses and resident acuity, on
the quality and timeliness of providing certain care tasks defined as
delayed and omitted care respectively. This simulation model is
important to add to existing literature on delayed care and help the
staffing study reflect not just what staffing levels exist currently as
a descriptive model, but also what staffing levels are needed for safe,
quality care for residents at varying acuity levels for the studied
clinical tasks.
As stated in the 2022 Nursing Home Staffing Study report,\60\ which
will be published concurrently with this proposed rule, simulation
findings suggest that a staffing level of four licensed nurses (that
is, a combination of RNs and LPN/LVNs) in this setting, would reduce
the amount of delayed or omitted care for the clinical tasks studied to
a rate below 5 percent in a 70-resident nursing home. Five licensed
nurses would virtually eliminate delayed or omitted care in this
setting. The 4 to 5 licensed nurses correspond to approximately 1.4 to
1.7 HPRD at such a nursing home. However, the study has several
limitations. One is that these study observations did not differentiate
between RN and LPN/LVN tasks, so we are unable to separate estimates of
potential delayed or omitted care for an RN versus an LPN. Most
importantly, simulation studies did not incorporate any patient-level
data or facility-level data from site observations. Instead,
simulations estimated patient acuity using MDS data. Therefore, patient
acuity in simulations were based on population-level estimates, rather
than estimates at the nursing-home level or the individual patient
level.
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\60\ Abt Associates. (2022). Nursing Home Staffing Study
Comprehensive report. Report prepared for the Centers for Medicare &
Medicaid Services. <a href="https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf">https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf</a>.
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Because the simulation did not use actual patient- or facility-
level data, facilities specializing in treatment of high or low acuity
residents were not properly represented in the staffing simulation
models. For example, different staffing needs may arise in facilities
specializing in care for persons experiencing disabilities resulting in
paraplegia/quadriplegia, or in facilities specializing in persons
experiencing advanced cognitive impairment. Analysis of specialized
care facilities was outside of the scope of this simulation research.
Furthermore, other existing simulation research focused on NAs only, so
NAs were considered as part of the evidence base for this work but were
not included in the analysis.
(4) Quantitative Analysis
Secondary Analysis: The quantitative analysis used secondary data
of nursing homes (n = 14,529) from the CMS' PBJ System, the MDS 3.0,
Medicare cost reports, and health inspection surveys to establish
minimum staffing standards for different types of nurse staff (that is,
total nurse staffing and individual RNs, LVN/LPNs, and NAs) and for
non-nurse staff (that is, social workers, feeding assistant, other
activities staff, and physical therapy assistant among others) that is
associated with an acceptable quality of care and safety in nursing
homes. Quality was defined based on a total composite quality measure
made up of Short-Stay Measures (that is, community discharge, hospital
readmissions, emergency department visits, Functional improvement) and
Long-Stay Measures (that is, activities of daily living decline,
antipsychotic medication use, mobility decline, high-risk pressure
ulcer, hospitalizations, and emergency department visits).\61\
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\61\ Abt Associates. (2022). Nursing Home Staffing Study
Comprehensive report. Report prepared for the Centers for Medicare &
Medicaid Services. <a href="https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf">https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf</a>.
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Safety was measured based on the relative on-site health inspection
performance of nursing homes within a State using surveys for the
following deficiencies: Immediate jeopardy to resident health or
safety; Actual harm that is not immediate jeopardy; No actual harm with
potential for more than minimal harm that is not immediate jeopardy;
and, No actual harm with potential for minimal harm.
Similar to other CMS nursing home improvement quality initiatives
such as Value Based Payment for nursing homes, acceptable quality and
safety was defined using the 25th and 50th percentile cut-offs on the
current distribution of the total quality measure (QM) score and
within-State performance on health inspection survey data, based on the
predicted probability of nursing homes exceeding the threshold across
the full distribution of nurse staffing levels. Moreover, some

[[Page 61363]]

nursing homes are staffed at levels that place their residents at
substantially higher risk of poor quality (for example, being in the
lowest quartile of QM score, defined as the 25th percentile cut off)
and low safety (for example, lowest quartile of performance on health
inspection survey, defined as the 25th percentile cut off). The PBJ
System data for the fourth quarter of 2019 through the first quarter of
2022, for 14,688 Medicare and/or Medicaid certified nursing homes in
the United States were included in the analyses.
Descriptive analyses examined HPRD for nurse and non-nurse staff in
nursing homes (n=14,529) across all States. Regression modeling
analyses controlled for case-mix adjusted data for nurse staffing (that
is, RN, LPN/LVN, and NA), LTC facility ownership (for example, non-
profit, Government), percent of Medicaid residents, hospital-based
facility, Continuing Care Retirement Community (CCRC) facility, rural
location, number of certified beds (per 1-bed increase), and Special
Focus Facility status. Using a correlational descriptive analysis,
findings indicate that there is a consistent positive relationship
between higher RN staffing and better performance, regardless of the
measure (that is, total quality measure score or within-State health
inspection score), the performance standard (that is, acceptable
quality and safety at the 25th, or 50th percentile), or the case-mix
adjusted RN staffing decile measured in HPRD.
Among all nurse staffing types, RNs exhibit the strongest
association with acceptable quality (p<.0001, significant at [alpha] =
0.05) and safety (pHowever, similar to previous
analyses,62 63 64 this study found no relationship between
LPN/LVNs HPRD levels and quality care and safety. This finding may be
influenced by the LPN/LVN's role \65\ and the fact that nursing homes
with higher LPN/LVN staffing levels tend to have lower RN staffing
levels.\66\ The volume and number of HPRD reported in PBJ System for
non-nurse staff were very low, ranging from 0.00-0.11; as such were
insufficient to examine further for establishing minimum non-nurse
staffing standards.
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\62\ Akinci, Fevzi, and Diane Krolikowski. ``Nurse staffing
levels and quality of care in Northeastern Pennsylvania nursing
homes.'' Applied nursing research: ANR vol. 18,3 (2005): 130-7.
doi:10.1016/j.apnr.2004.08.004.
\63\ Yang, Bo Kyum et al. ``Nurse Staffing and Skill Mix
Patterns in Relation to Resident Care Outcomes in US Nursing
Homes.'' Journal of the American Medical Directors Association vol.
22,5 (2021): 1081-1087.e1. doi:10.1016/j.jamda.2020.09.009.
\64\ Spilsbury, Karen et al. ``The relationship between Nurse
staffing and quality of care in nursing homes: a systematic
review.'' International journal of nursing studies vol. 48,6 (2011):
732-50. doi:10.1016/j.ijnurstu.2011.02.014.
\65\ Firnhaber, G.C., Roberson, D.W., & Kolasa, K.M. (2020).
Nursing staff participation in end-of-life nutrition and hydration
decision-making in a nursing home: A qualitative study. Journal of
Advanced Nursing, 76(11), 305-3068.https://<a href="http://doi.org/10.1111/jan.14491">doi.org/10.1111/jan.14491</a>.
\66\ Abt Associates. (2022). Nursing Home Staffing Study
Comprehensive report. Report prepared for the Centers for Medicare &
Medicaid Services. <a href="https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf">https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf</a>.
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We considered findings from the 2022 Nursing Home Staffing Study,
specifically that there was no statistically significant difference in
safety and quality care below 2.45 HPRDs for NAs. In other words,
staffing below 2.45 HPRD for NAs did not improve safety and quality
care for LTC facility residents. Also, our proposed NA requirement of
2.45 HPRD which was developed using case-mix adjusted data sources, is
higher than the minimum requirements in all States and DC, based on
data reported in September 2022.
We also considered findings from the 2022 Nursing Home Staffing
Study that there was no correlation between safety and quality care,
and LVN/LPNs. We examined findings from the 2022 Nursing Home Staffing
Study, that there was a statistically significant difference in safety
and quality care at 0.45 HPRD for RNs and higher. We also factored the
minimum RN requirements in all States and the District of Columbia,
which with the exception of two States, all had less than the 0.45 HPRD
for RNs, which was the lowest level presented in the 2022 Nursing Home
Staffing Study. However, current State minimum RN staffing levels are
associated with increased risk for unsafe and poor quality care.
Therefore, we are proposing the level of 0.55 HPRD for RNs, which was
developed based on case-mix adjusted data sources and the 2022 Nursing
Home Staffing Study findings. In addition, 0.55 HPRD for RNs will
result in a large majority (78 percent) of LTC facilities increasing
staffing to provide safe and quality care. CMS is also seeking comments
on whether in addition to the 0.55 RN and 2.45 NA HPRD standards, a
minimum total nurse staffing standard, such as 3.48 among other
alternatives, discussed later in the rule, should also be required.
Furthermore, we considered striking a balance between cost and
benefit for LTC facilities, nursing staff, and residents, and the
minimum number of HPRDs by staff type that will improve safety and
quality care. Therefore, we proposed 0.55 and 2.45 HPRD for RNs and
NAs, respectively, which were developed using case-mix adjusted data
sources, because we believe that proposing lower staffing levels than
current State requirements would be insufficient to meet the statutory
goals of improving health and safety.
Impact Analysis: The impact of State minimum staffing policies on
nurse staffing, and safety and quality care in nursing homes during the
recent COVID-19 PHE, can inform policy makers on potential outcomes to
Federal minimum staffing standards. The study also provided analyses of
the recently revised Massachusetts minimum staffing standards, in the
wake of the COVID-19 PHE, making the findings the most timely and
relevant of various State-level analyses. The researchers determined
that the analysis of the Massachusetts staffing standard would be
particularly informative given that the State increased its HPRD to a
relatively high level and incorporated a Medicaid payment reduction of
2 percent for noncompliant facilities. As such a quasi-experimental
study was conducted to determine the impact of the Massachusetts
minimum staffing standards on quality of care and safety in nursing
homes.
The Massachusetts nursing home minimum staffing standards requires
3.58 HPRD for total nurse staffing (that is, RN, LPN, and NA), of which
0.508 HPRD was for an RN, and provided for a financial penalty for
noncompliance with the total nurse staffing standard. The study period
was defined as 2015 Q3 through 2022 Q2. The Massachusetts nursing home
minimum staffing policy was effective January 1, 2021. Impact analysis
of existing nursing homes (n=40) data from the PBJ System data (2015Q3-
2022Q2) and Care Compare (quality measure and health inspection survey
data) were used. The comparison group selected from the sample of
national nursing homes (n=1,617) was constructed using a synthetic
control approach. Synthetic control is a statistical method for
creating a comparison group of nursing homes from a region that did not
experience the same health policy intervention, but closely resembles
the nursing home staffing level and trend in Massachusetts using
weighted estimates. Difference-in-differences regression analyses were
conducted by stratified nursing home Medicaid share and staffing level.
Difference-in-differences regression is a statistical method for
estimating the causal effect of the Massachusetts minimum staffing
standards, when compared to a region that did not experience the same
policy intervention.

[[Page 61364]]

These regression models did not find a discernible impact on
quality of care nor safety within the time period studied. They did,
however, find an increase in total nurse staffing levels among low-
staffed nursing homes with a high share of residents with Medicaid in
Massachusetts. The observed staffing increase was significant for NAs
(average treatment effect on the treated (ATT)=.179, p=0.03). The
analysis thus demonstrates that nursing homes were able to expand
staffing in response to the new requirement, notwithstanding workforce
challenges since the pandemic.
One limitation of the analysis was the small number of nursing
homes included because the analysis focused on a subset of nursing
homes with the strongest incentive to respond to the new policy, that
is, those with high Medicaid resident shares (>= 75th percentile) and
initial staffing levels below the new Massachusetts minimum staffing
requirement (HPRD <= 3.58 for total nurse staffing), resulting in 1,617
out of 15,333 nursing homes nation-wide for the control group, and 40
out of 373 nursing homes in Massachusetts. Also, about one third of the
nursing homes did not complete health inspection surveys due to the
COVID-19 PHE, so there was a substantial amount of missing data for
examining the safety outcome. Furthermore, the analysis of quality of
care and safety outcomes was limited by the short post-implementation
study period of Massachusetts's minimum staffing standards, which does
not allow for sufficient time for a complete evaluation of the policy.
Additionally, the impact analysis was focused on data from roughly the
first year of implementation, which usually involves resource planning
and operational changes to meet the new policy standards, and thus may
not be representative.
These study results show that there was an increase in NA staffing,
which supports the proposed policy to require facilities to meet the
minimum staffing standards or otherwise be subject to, civil money
penalties and denial of payment for all Medicare and/or Medicaid
individuals among other penalties in accordance with 42 CFR 488.406.
(5) Cost and Savings Analysis
The cost analyses were conducted to determine any associated
incremental costs that nursing homes would likely experience to meet
minimum staffing standards, as well as any Medicare savings. Cost
analyses used the 2021 Q2 PBJ System (staffing data), facility-specific
information on hourly costs for RNs, LPN/LVNs, and NAs from Worksheet
S-3, FY 2021 Part V of the Medicare Cost Report for 14,688 SNFs, and
information on resident census that is available from files produced
for comparison to evaluate any associated incremental costs. We note
that the cost analyses were independent of a facility's case-mix.
Study findings indicate that the staffing costs for increasing RN
and NA staffing levels in nursing homes to meet the minimum staffing
standards ranges from $2.2 to $6.0 billion per year. The minimum
estimated cost savings to Medicare, based on savings from the RN
staffing requirement, are from the decreased use of acute care services
(fewer hospitalizations and emergency department visits) and increased
community discharges (defined as a reduction in Medicare-covered SNF
days); cost savings ranges from $187 to $465 million. The decision to
focus on estimated savings for RNs only, was because RN staffing levels
were found to have a much stronger and a more consistent positive
correlation with hospitalizations and emergency department visits than
NAs or LPNs.
These quantitative analyses of savings to Medicare were limited to
quality metrics for which there are extant secondary data. However,
there are likely additional benefits to quality of care and life that
cannot be fully identified through the analysis in the 2022 Nursing
Home Staffing Study. Moreover, these analyses do not consider
facilities' existing resources, ability to pay for possible staffing
levels, or access to trained healthcare professionals.
Overall, the study \67\ was unable to examine the relationship
between staffing levels by shift and quality/patient safety because the
PBJ System does not include information on staffing by shift. In
addition, there was limited information on non-nurse staffing, so the
study team was unable to examine minimum staffing standards for non-
nurse staff.
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\67\ Abt Associates. (2022). Nursing Home Staffing Study
Comprehensive report. Report prepared for the Centers for Medicare &
Medicaid Services. <a href="https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf">https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf</a>.
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c. Listening Sessions
In addition to commissioning the 2022 Nursing Home Staffing Study
and issuing the FY 2023 SNF PPS RFI, we also held two listening
sessions on June 27, 2022, and August 29, 2022, to provide information
on the study and solicit additional input on the study design and
approach for establishing minimum staffing standards. The first
listening session was attended by 18 interested parties representing
various groups within the LTC community. During this session, this
small group discussed several ``big picture'' questions about minimum
staffing standards and provided input on the overall study approach.
The second listening session was attended by 668 participants who
offered feedback on specific questions that were included on the
registration form, such as how to ensure that health equity/health care
disparities are addressed when establishing minimum nurse staffing
standards and how minimum staffing standards should consider
differences in costs for job categories and variations across States.
During the August 2022 listening session,\68\ participants shared
their opinions that the current state of staffing standards was not
adequate, and there was consensus that minimum staffing standards
should be the same across the country. Participants recommended that
CMS consider resident characteristics and care needs when developing
staffing standards. Participants indicated that the interdisciplinary
team and the care provided by non-nursing staff such as physical,
occupational, speech therapists, respiratory therapists (especially
with pediatric specialty/ventilator units), podiatrists, and
psychiatrists also need to be considered. Others also suggested that
the inclusion of non-nurse staff to meet staffing standards may
positively contribute to aspects of quality of life for residents.
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\68\ <a href="https://www.cms.gov/nursing-homes">https://www.cms.gov/nursing-homes</a>.
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Similar to the suggestions received in the FY 2023 SNF PPS RFI,
some participants suggested that CMS create a staff-to-resident ratio
minimum standard, which can further support a HPRD staffing standard.
Participants also suggested that facilities should report and display
staff-to-resident ratios on a daily basis for all shifts. Participants
in favor of a staff-to-resident ratio requirement noted that increased
transparency will help residents and family members to easily determine
if the facility is in compliance with minimum staffing standards.
Lastly, some participants indicated that minimum staffing standards
should consider the need for consistent NA qualifications across all 50
States and to allow for more online training to eliminate the backlog
of availability for NAs testing and increase the availability of
classes near candidates to support staff shortages.

[[Page 61365]]

4. Ongoing CMS Initiatives and Programs Impacting LTC Facilities
In establishing the proposed minimum staffing standards, we also
considered ongoing CMS policies, programs, and operations, including
Medicaid institutional payment and transparency, the SNF prospective
payment system, the SNF Value-based Purchasing Program (SNF VBP),
oversight and enforcement, and CMS policies intended to enhance access
to Medicaid home and community-based services and promote community-
based placements.
a. Medicaid Institutional Payments and Payment Transparency
In this proposed rule we are also proposing a Medicaid
Institutional Payment Transparency provision that is intended to
promote public payment transparency. Greater transparency will help us
assess the extent to which LTC facilities with a large Medicaid
population have challenges achieving compliance with minimum staffing
standards. State Medicaid Agencies would be required to publicly report
the percentage of payments expended for direct care workers and support
staff services in Medicaid-participating nursing facilities and
Intermediate Care Facilities for Individuals with Intellectual
Disabilities (ICF/IID) (see section III. of this proposed rule). We
expect that as a result of this transparency requirement, some
facilities would likely increase staffing independent of our proposed
minimum staffing standards.
b. Medicare Skilled Nursing Facility Prospective Payment System
The Medicare Skilled Nursing Facility Prospective Payment System is
a comprehensive per diem rate under Medicare for all costs for
providing covered Part A SNF services (that is, routine, ancillary, and
capital-related costs). There are over 15,000 Medicare-certified SNFs.
The FY 2023 SNF PPS proposed rule published on April 4, 2023 updated
Medicare payment policies and rates for SNFs for FY 2024. The FY2023
SNF PPS proposed rule estimated that the aggregate impact of the
payment policies in the rule would result in a net increase of 3.7
percent, or approximately $1.2 billion, in Medicare Part A payments to
SNFs in FY 2024. We note that Section 1888(e)(4)(E) of the Act requires
the SNF PPS payment rates to be updated annually. These updates take
into account a number of factors, including but not limited to, wages,
salaries, and other labor-related costs. Specifics regarding the
process to update SNF PPS payment rates are discussed in the rule.\69\
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\69\ Medicare Program; Prospective Payment System and
Consolidated Billing for Skilled Nursing Facilities; Updates to the
Quality Reporting Program and Value-Based Purchasing Program for
Federal Fiscal Year 2024. <a href="https://www.federalregister.gov/documents/2023/04/10/2023-07137/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities">https://www.federalregister.gov/documents/2023/04/10/2023-07137/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities</a>.
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c. Skilled Nursing Facility (SNF) Value-Based Payment (VBP) Program
Staffing Measure
In the FY 2023 SNF PPS final rule, we adopted a new Total Nurse
Staffing quality measure under the SNF VBP Program, which is used to
provide an incentive to LTC facilities for improving quality of care
provided to residents.\70\ Performance on the Total Nurse Staffing
measure begins in FY 2024, and payment adjustments based on performance
on this measure (as well as others) occurs in FY 2026. This is a
structural measure that uses auditable electronic data reported to CMS'
PBJ system to calculate HPRD for total nurse staffing. Our proposal is
not to be duplicative of this existing measure; rather, we expect our
proposed minimum staffing standards to be complementary by establishing
a consistent and broadly applicable national floor at which residents
are at a significantly lower risk of receiving unsafe and low-quality
care. At the same time, the Total Nurse Staffing quality measure will
drive continued improvement in staffing across LTC facilities.
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\70\ <a href="https://www.cms.gov/newsroom/fact-sheets/fiscal-year-fy-2023-skilled-nursing-facility-prospective-payment-system-final-rule-cms-1765-f">https://www.cms.gov/newsroom/fact-sheets/fiscal-year-fy-2023-skilled-nursing-facility-prospective-payment-system-final-rule-cms-1765-f</a>.
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d. Nursing Home Survey and Enforcement
The LTC minimum staffing standards proposed in this regulation are
part of the Federal participation requirements for LTC facilities and
these Federal participation requirements are the basis for survey
activities and for the minimum health and safety requirements that must
be met and maintained to receive payment and remain as a Medicare or
Medicaid provider. As such compliance with these requirements will be
assessed through CMS' existing survey, certification, and enforcement
process.\71\ Enforcement actions taken against LTC facilities that are
not in compliance with these Federal participation requirements are
called remedies. The agency that conducts on-site surveys cites
deficiencies that indicate the specific Federal participation
requirements that the facility did not meet. Sections 1819(h) and
1919(h) of the Act, as well as 42 CFR 488.404, 488.406, and 488.408,
provide that CMS or the State may impose one or more remedies in
addition to, or instead of, termination of the provider agreement when
the CMS or the State finds that a facility is out of compliance with
the Federal participation requirements. Specifically, enforcement
remedies that may be imposed include the following:
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\71\ <a href="https://www.cms.gov/medicare/provider-enrollment-and-certification/surveycertificationenforcement/nursing-home-enforcement">https://www.cms.gov/medicare/provider-enrollment-and-certification/surveycertificationenforcement/nursing-home-enforcement</a>.
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<bullet> Termination of the provider agreement;
<bullet> Temporary management;
<bullet> Denial of payment for all Medicare and/or Medicaid
individuals by CMS;
<bullet> Denial of payment for all new Medicare and/or Medicaid
admissions;
<bullet> Civil money penalties;
<bullet> State monitoring;
<bullet> Transfer of residents;
<bullet> Transfer of residents with closure of facility;
<bullet> Directed plan of correction;
<bullet> Directed in-service training; and
<bullet> Alternative or additional State remedies approved by CMS.
In general, to select the appropriate enforcement remedy(ies), the
scope and severity levels of the deficiencies is assessed. The severity
level reflects the impact of the deficiency on resident health and
safety and the scope level reflects how many residents were affected by
the deficiency. The survey agency determines the scope and severity
levels for each deficiency cited at a survey.
As part of these survey and enforcement activities, we currently
publish data for all LTC facilities on the Care Compare website,
including number of certified beds, an overall Five Star rating, and
three individual star ratings in the categories of inspections,
staffing, and quality measurement.\72\ In addition, individual
performance measures are included on Care Compare. With respect to
staffing, this includes the following staffing data: total number of
nurse staff HPRD, RN HPRD, LPN/LVN HPRD, and NA HPRD, as well as some
additional staffing measures, including weekend hours. These published
data are collected through a variety of mechanisms, including during
CMS surveys (inspection data), through the reporting

[[Page 61366]]

of PBJ System and are also self-reported by LTC facilities to us.
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\72\ Centers for Medicare & Medicaid Services <a href="http://Medicare.gov">Medicare.gov</a>. Find
and Compare Nursing Homes Providers near you <a href="https://www.medicare.gov/care-compare/?providerType=NursingHome&redirect=true">https://www.medicare.gov/care-compare/?providerType=NursingHome&redirect=true</a>.
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In general, facilities report employing three types of nursing
staff: RNs, LPNs/LVNs, and NAs. We have been moving towards more data-
driven enforcement, including use of the self-reported PBJ System data
to guide monitoring, surveys and enforcement of existing staffing
requirements. We continue to recognize the value of assessing the
sufficiency of a facility's staffing based on observations of resident
care conducted during the onsite survey. For example, while compliance
with numeric minimum staffing standards could be assessed using PBJ
System data, it is possible that due to a facility's layout,
management, and staff assignments, a facility could meet the numeric
staffing standards but not provide the sufficient level of staffing
needed to protect residents' health and safety. Resident health status
and acuity (for example, proportion of residents with cognitive decline
or use of ventilators) are also factors in determining adequate
staffing. Therefore, when assessing the sufficiency of a facility's
staffing it is important to note that any numeric minimum staffing
requirement is not a target and facilities must assess the needs of
their resident population and make comprehensive staffing decisions
based on those needs. The additional requirements proposed in this rule
to bolster facility assessments are intended to address this need and
guard against any attempts by LTC facilities to treat the minimum
staffing standards included here as a ceiling, rather than a floor.
In summary, the benefits and success of minimum staffing standards
are heavily dependent on the survey process. Therefore, in establishing
numerical minimum staffing standards our goal is to ensure that they
are both implementable and enforceable, as determined through both the
PBJ System as well as on-site surveys.
e. Medicaid Home and Community-Based Services
We remain committed to a holistic approach to meeting the long-term
care needs of Americans and their families. This requires a focus on
access to high-quality care in the community while also ensuring the
health and safety of those who receive care in LTC facilities. In the
proposed April 2023 Ensuring Access to Medicaid Services (Access NPRM)
and Medicaid and CHIP Managed Care Access, Finance, and Quality
(Managed Care NPRM), we proposed several policies intended to work
alongside those included in this proposed rule. These proposals require
that at least 80 percent of Medicaid payments for personal care,
homemaker and home health aide services be spent on compensation for
the direct care workforce (as opposed to administrative overhead or
profit); establish standardized reporting requirements related to
health and safety, beneficiary service plans and assessments, access,
and quality of care; and promote transparency through public reporting
on quality, performance, compliance as well as Medicaid managed care
plans' payment rates for direct care workers. Additionally, we remain
committed to facilitating transfers from LTC facilities to the
community through the continued implementation of the Money Follows the
Person program.\73\
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\73\ Money Follows the Person [bond] Medicaid, <a href="https://www.medicaid.gov/medicaid/long-term-services-supports/money-follows-person/index.html">https://www.medicaid.gov/medicaid/long-term-services-supports/money-follows-person/index.html</a>.
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Notably, we believe that the proposed minimum staffing standards
will improve quality of care which includes facilitating the transition
of care to community based care services; similar to findings that are
reported in the 2022 Nursing Home Staffing Study as well as potential
Medicare savings.

B. Provisions of the Proposed Regulations

As discussed above, meeting minimum staffing standards may be
influenced by and/or affect existing CMS initiatives and programs, and
programs within LTC facilities. Given these factors and the broad
spectrum of suggestions and inputs discussed, we acknowledge that there
are many considerations and potential policy options for establishing
minimum staffing standards. Therefore, we propose a comprehensive
staffing approach that consists of the three following elements: (1)
establishing new minimum nurse staffing standards based on case-mix
adjusted staffing; (2) revising the on-site RN requirement; and (3)
revising the existing facility assessment requirement. We believe, when
taken together, these three elements will establish a consistent and
broadly applicable national minimum staffing standards as a floor,
while also ensuring that LTC facilities staff beyond the minimum
staffing standards as needed, based on their resident population.
While we expect LTC facilities to meet the comprehensive staffing
standards, we acknowledge that there may be circumstances related to
the nursing workforce that require efforts to both ensure access to
care and maintain quality care and safety. Therefore, we are proposing
options for exemptions and a staggered implementation of the proposal's
components for meeting the minimum staffing standards. This
comprehensive approach aims to strike the appropriate balance between
ensuring resident health and safety, while guarding against unintended
consequences, and preserving access to care.
Our goal is to protect resident health and safety and ensure that
facilities are considering the unique characteristics of their resident
population in developing staffing plans, while balancing operational
requirements and supporting access to care. Moreover, the comprehensive
staffing standards will provide staff with the support they need to
safely care for residents.
We believe that the elements of the proposed comprehensive staffing
standards discussed in this rule support these goals and align with the
key function of the LTC facility participation requirements, which is
to establish minimum standards to ensure safety and quality care for
all residents.
We also acknowledge the impact that proposed minimum staffing
standards will have on the LTC facility industry and recognize the
potential for unintended consequences, such as facilities'
misinterpretation of the minimum staffing standards. Such
misinterpretation could result in inappropriate behaviors, such as
choosing to staff only at the minimum RN and NA HPRD requirements,
without adequate consideration of facility characteristics and resident
acuity and needs; healthcare workforce substitution (hiring for one
position by eliminating another); task diversion (assigning non-
standard tasks to a position); or gamesmanship around composition of
the patient population (avoiding residents with more complex medical
needs). Such actions would not result in the improved safety, quality,
and person-centered care that we seek in facilities. As such, we are
soliciting public comments on the policy proposals outlined below, in
particular the feasibility of the proposals, any unintended
consequences, and alternatives that we should consider. We will
consider all feedback to inform the final policy.
1. Nursing Services (Sec. 483.35)
a. Sufficient Staff (Sec. 483.35(a)(1))
In general, LTC facilities report employing three types of nursing
staff: RNs, LPN/LVNs, and NAs. RNs are assigned both administrative
roles and resident assessment and care planning, which typically
results in less hands-on

[[Page 61367]]

time with residents and more non-clinical skills (for example,
managerial and time management skills). They are able to assess
resident health problems and needs, develop and implement care plans,
and maintain medical records. LPN/LVNs are entry-level licensed nurses
providing basic level care under a RN or physician supervision such as
checking blood pressure, changing bandages and dressings, and
documenting patient care records. NAs spend the most time providing
care to residents by assisting with activities of daily living (for
example, feeding, bathing, and dressing). Moreover, roles for NAs may
differ from LPN/LVNs depending on the State.
NAs are paid on average $16.90/hour, whereas RNs and LVN/LPNs are
paid an average hourly wage of $37.11 and $28.17 in Nursing Care
Facilities.\74\ While the work of NAs and other direct care workers,
like home health aides and personal care assistants, requires
considerable technical and interpersonal skills, these workers
historically receive low pay, rarely receive benefits, and experience
high injury rates.\75\ Despite the rising demand for services, direct
care workers continue to earn poverty-level low wages. Almost one-half
of the direct care workforce (45 percent) live below 200 percent of the
Federal poverty level and about one-half (47 percent) rely on public
assistance. Recent research by the U.S. Assistant Secretary for
Planning and Evaluation finds that wages for direct care workers,
including NAs, lag behind workers in other industries with similar
entry-level requirements, exacerbating recruitment and retention
challenges. According to its findings, average hourly wages also vary
considerably State to State--as low as $10.90 for NAs in Louisiana to
as high as $18.66 in Alaska.
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\74\ Nursing and Residential Care Facilities--May 2022 OEWS
Industry-Specific Occupational Employment and Wage Estimates
(<a href="http://bls.gov">bls.gov</a>).
\75\ Wages of Direct Care Workers Lower than Other Entry Level
Jobs in most States, Assistant Secretary for Planning and
Evaluation, April, 2023 <a href="https://aspe.hhs.gov/reports/dcw-wages">https://aspe.hhs.gov/reports/dcw-wages</a>.
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Current regulations at Sec. 483.35(a)(1)(i) and (ii) require
facilities to have sufficient numbers of licensed nurses and other
nursing personnel, including but not limited to NAs, available 24 hours
a day to provide nursing care to all residents in accordance with the
resident care plans.\76\ In the 2016 LTC final rule mentioned
previously,\77\ CMS described the complexity of establishing minimum
staffing standards at that time given that the PBJ System reporting
program had only been recently implemented. Therefore, we did not have
adequate information in terms of facility-level staffing data that
would be needed to establish minimum staffing standards. We further
stated that once a sufficient amount of data was collected and
analyzed, we could re-visit the establishment of minimum staffing
standards in LTC facilities. As of calendar year 2022, we have access
to about 6 years of self-reported data from the PBJ System which are
sufficient to examine the staffing issues in LTC facilities that still
persist and were exacerbated by the COVID-19 PHE.
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\76\ 42 CFR 483.35 <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2022/02/28/fact-sheet-protecting-seniors-and-people-with-disabilities-by-improving-safety-and-quality-of-care-in-the-nations-nursing-homes/">https://www.whitehouse.gov/briefing-room/statements-releases/2022/02/28/fact-sheet-protecting-seniors-and-people-with-disabilities-by-improving-safety-and-quality-of-care-in-the-nations-nursing-homes/</a>.
\77\ Medicare and Medicaid Programs; Reform of Requirements for
Long-Term Care Facilities. (81 FR 68688) <a href="https://www.federalregister.gov/documents/2016/10/04/2016-23503/medicare-and-medicaid-programs-reform-of-requirements-for-long-term-care-facilities">https://www.federalregister.gov/documents/2016/10/04/2016-23503/medicare-and-medicaid-programs-reform-of-requirements-for-long-term-care-facilities</a>.
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According to CMS survey and enforcement data, over 1,000 facilities
were cited for insufficient staffing in 2022 and residents, family,
ombudsmen, researchers, and others continue to report to CMS that
understaffing negatively affects care. There is also considerable
variation in State staffing requirements. As previously stated, a
review of State staffing requirements indicates that 38 States and the
District of Columbia currently have minimum staffing standards in LTC
facilities, but these standards differ across States by staff types,
hours and measurement across States, and more so during the COVID-19
PHE.\78\ The proposed RN requirement of 0.55 HPRD is higher than every
State, and only lower than the District of Columbia. The proposed NA
requirement of 2.45 HPRD is higher than all States and the District of
Columbia, based on data from September 2022.
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\78\ State Policies Related to Nursing Facility (NF) Staffing
<a href="https://www.macpac.gov/wp-content/uploads/2022/03/State-Policies-Related-to-Nursing-Facility-Staffing.xlsx">https://www.macpac.gov/wp-content/uploads/2022/03/State-Policies-Related-to-Nursing-Facility-Staffing.xlsx</a>.
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For example, only 10 States out of the 38 States have minimum HPRD
standards for NAs ranging from 1.04 to 2.44 (see Table 2).

Table 2--HPRD Requirement for NAs by State
------------------------------------------------------------------------
CNAs
State (HPRD)
------------------------------------------------------------------------
1. California................................................ 2.4
2. Delaware.................................................. 1.6
3. Florida [Dagger].......................................... 2.0
4. Montana................................................... 1.2
5. New Jersey................................................ 1.04
6. New York.................................................. 2.2
7. Oregon.................................................... 2.16
8. Rhode Island.............................................. 2.44
9. South Carolina............................................ 1.63
10. Vermont.................................................. 2.0
------------------------------------------------------------------------
Notes: CNAs= certified nursing assistants or nursing assistants; HPRD=
hours per resident day.
[Dagger] FL revised CNA HPRD from 2.45 to 2.0 on 4/2022.
Source: RTI International, 2021, Review of State Policies Related to
Nursing Facility Staffing.

Some States have implemented a total hour per resident day (HPRD)
model, with some including licensed nurses in this calculation, whereas
others exclude LPN/LVNs but include RNs, DONs, and NAs only. For
example, the District of Columbia requires a minimum daily average of
4.1 hours of direct nursing care per resident per day (with an
opportunity to adjust the requirements above or below this level, as
determined by the Director of the Department of Health), an RN on site
24 hours a day, 7 days a week, plus additional nursing and medical
staffing requirements.\79\ Some States implemented a ratio of numbers
of full-time equivalent NAs per resident. For example, California
requires 3.5 HPRD for total nurse staffing with at least 0.24 of those
hours provided by RNs, and 2.4 HPRD for NAs, and no HPRD required for
LPN/LVNs. Massachusetts requires 3.58 HPRD for total nurse staffing
with at least 0.508 of those hours provided by a RN.\80\ Arkansas
requires at least 3.36 average HPRD for nurse and non-nurse staff each
month to include licensed nurses, NAs, medication assistants,
physicians, physician assistants, licensed physical or occupational
therapists or licensed therapy assistants, registered respiratory
therapists, licensed speech language pathologists, infection
preventionists, and other healthcare professionals licensed or
certified in the State, plus requirements for minimum numbers of
licensed nurses per residents per shift. There is also limited evidence
on how these different staffing standards were developed and their
impact.
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\79\ <a href="https://doh.dc.gov/sites/default/files/dc/sites/doh/publication/attachments/Nursing_Facility_Regulations_Health_Care_Facilities_Improvement_2012.pdf">https://doh.dc.gov/sites/default/files/dc/sites/doh/publication/attachments/Nursing_Facility_Regulations_Health_Care_Facilities_Improvement_2012.pdf</a>.
\80\ <a href="https://theconsumervoice.org/uploads/files/issues/CV_StaffingReport.pdf">https://theconsumervoice.org/uploads/files/issues/CV_StaffingReport.pdf</a>.

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[[Page 61368]]

The 2022 Nursing Home Staffing Study \81\ included an analysis of
PBJ System data for the fourth quarter of 2019 through the first
quarter of 2022. The 2022 Nursing Home Staffing Study, as discussed
previously, provided CMS with findings to inform the proposal for
minimum staffing standards, and discussed trade-offs associated with
balancing cost and feasibility with implications for acceptable quality
care and safety, especially among the lowest performing facilities
(that is, at or below the 25th percentile for total safety and quality
measure scores) that are at the most risk for providing unsafe care.
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\81\ Abt Associates. (2022). Nursing Home Staffing Study
Comprehensive report. Report prepared for the Centers for Medicare
and Medicaid Services. <a href="https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf">https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf</a>.
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After considering all of the available evidence and extensive
comments provided, we are proposing revisions to the Nursing Services
regulations at Sec. 483.35 to establish national, quantitative minimum
staffing standards to ensure all facilities provide at least the same
baseline level of high-quality and safe care to residents across all
participating LTC facilities. We propose to revise Sec.
483.35(a)(1)(i) and (ii) to further define ``sufficient numbers'' by
establishing a numerical minimum level for HPRD for RNs and NAs. We
also propose to revise Sec. 483.5 to include the definition of ``hours
per resident day'' (HPRD), that is, staffing hours per resident per day
is the total number of hours worked by each type of staff divided by
the total number of residents as calculated by CMS.\82\ Specifically,
at Sec. 483.35(a)(1)(i) we propose individual nurse staffing type
standards for RNs and NAs. We propose to require facilities to have
minimum staffing standards of 0.55 HPRD of RNs and 2.45 HPRD of NAs as
well as to maintain sufficient additional nursing personnel, including
but not limited to LPN/LVNs, and other clinical and non-clinical staff,
to ensure safe and quality care, based on the proposed facility
assessment requirements at Sec. 483.71. CMS is also seeking comments
on a minimum total nurse staffing standard of 3.48 HPRD discussed later
in the rule.
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\82\ <a href="https://data.cms.gov/provider-data/dataset/4pq5-n9py">https://data.cms.gov/provider-data/dataset/4pq5-n9py</a>.
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We are not proposing minimum nurse staffing standards that include
HPRD for licensed nurses (that is, RNs plus LPN/LVNs) nor for total
nurse staffing (that is, RNs, LPN/LVNs, and NAs). This proposed policy
is based on the 2022 Nursing Home staffing study findings and other
literature evidence demonstrating that RNs and NAs have a larger effect
on quality than LPN/LVNs. In addition, literature and statistical
evidence suggests that improved clinical outcomes are associated with
increasing the HPRD rates of RNs and NAs \83\ especially among nursing
homes that have a high reliance on Medicaid.\84\ Moreover, when LPN/
LVNs work with higher numbers of HPRD for RNs and NAs (that is, total
nurse staff) it appears to reduce delayed or omitted care and increase
gross cost savings to Medicare.\85\ We believe that establishing
national, numerical standards of direct care hours will improve safety
and quality in many LTC facilities. By creating a consistent Federal
floor for staffing expectations, we will better define the minimum
number of care hours residents should receive to protect health and
safety, while also facilitating strengthened oversight and enforcement.
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\83\ Abt Associates. (2022). Nursing Home Staffing Study
Comprehensive report. Report prepared for the Centers for Medicare
&and Medicaid Services. <a href="https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf">https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf</a>.
\84\ Bowblis J.R. (2011). Staffing ratios and quality: an
analysis of minimum direct care staffing requirements for nursing
homes. Health services research, 46(5), 1495-1516. <a href="https://doi.org/10.1111/j.1475-6773.2011.01274.x">https://doi.org/10.1111/j.1475-6773.2011.01274.x</a>.
\85\ Abt Associates. (2022). Nursing Home Staffing Study
Comprehensive report. Report prepared for the Centers for Medicare &
Medicaid Services. <a href="https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf">https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf</a>.
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As an example, when establishing the proposed HPRD level of 0.55
for RNs and 2.45 for NAs, we note that the minimum number of RN hours
(that is 0.55 HPRD) provided in a facility that has 100 residents and
runs an 8-hour shift per 24 hours, would require a total of 55 RN hours
per 24 hours.\86\ In other words, at least two RNs on staff each 8-hour
shift, plus a third RN for one shift, would be necessary in this
scenario although no per shift minimum is being established in this
rule. Similarly, the minimum number of NA hours (that is 2.45 HPRD)
provided in a facility that has 100 residents and runs an 8-hour shift
per 24 hours will require at least a total of 245 NA hours per 24
hours.\87\ In other words, at least 10 NAs on staff each 8-hour shift,
plus a third NA for one shift would be necessary in this scenario
although no per shift minimum is being established in this rule.
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\86\ 100 residents x 0.55HPRD = 55 RN hours for 24 hours; or 18
RN hours/8-hour shift; that is ~2 RNs.
\87\ 100 residents x 2.45HPRD = 245 NA hours for 24 hours; or 81
NA hours/8-hour shift; that is ~10 NAs.
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These proposed levels for hours of care would establish the minimum
nurse staffing levels needed to provide safe and high-quality nursing
services to each resident per day. We underscore that these standards
reflect only the absolute minimum floor adjusting for the average
acuity across all LTC facilities, and the required hours of nursing
care may be greater but never lower than the proposed minimum
standards, if the acuity needs of residents in a facility requires a
higher level of care. Additionally, the proposed staffing levels
require all facilities to meet at least this minimum floor, even if the
facility has below average acuity, given that resident population can
shift more rapidly than staffing plans; most facilities have either an
average acuity or higher of resident population; and as noted above,
the evidence can also support a higher range of staffing thresholds.
Notably, we are proposing to specify HPRD for RNs and NAs in the
minimum staffing requirement at Sec. 483.35(a) and are not proposing a
total nurse staffing level under which facilities have the flexibility
to decide between types of licensed nurses to meet the minimum
requirement. We have taken this approach given the evidence that shows
a strong positive association between RN staffing levels and safety and
quality, as well as NA staffing levels at higher HPRDs. Literature
evidence also indicates that the increased presence of RNs in nursing
facilities would help address several issues.
First, research evidence suggests that greater RN presence has been
associated with higher quality of care and fewer deficiencies. Second,
it has been reported in the literature that where standards provide
flexibility as between types of licensed nurses (that is, do not
specify RN hours), LPN/LVNs may find themselves practicing outside of
their scope of practice partly because there are not enough RNs
providing direct patient care and supervision of LPN/LVNs. The
specificity of this approach would increase the number of hours per day
that a LTC facility must have RNs in the facility and would alleviate
concerns about LPN/LVNs engaging in activities outside their scope of
practice in the face of resident need during times when no RN is on
site (80 FR 42168, 42200). Moreover, to prevent a high rate of unusual
patient safety events, the National Academy of Medicine (NAM) (formerly
the Institute of Medicine (IOM)) suggests having adequate staffing
levels, specifically NAs, who provide most of the care to nursing home
residents.\88\ In addition, our proposal,

[[Page 61369]]

which focuses on sufficient numbers of nursing staff, does not
contemplate staffing levels for non-nursing staffing because nursing
staff are most critical to ensuring minimum standards of care, and
there is insufficient information on non-nurse staffing levels in the
PBJ System and other available data sources that limits our efforts to
examine staffing requirements for non-nurse staff at this time. We
solicit comment on the need to allow for substitution, such as
substituting LPN/LVNs for NAs, in extraordinary cases and specifically
what extreme circumstances would appropriately allow for such
substitution.
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\88\ Institute of Medicine (US) Committee on the Work
Environment for Nurses and Patient Safety. Keeping Patients Safe:
Transforming the Work Environment of Nurses. Edited by Ann Page,
National Academies Press (US), 2004. doi:10.17226/10851.
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As noted, based on the findings reported in the 2022 Nursing Home
Staffing Study, information gathered through the FY2023 SNF PPS RFI,
listening sessions, assessment of the PBJ System data, and review of
the literature evidence, we are proposing individual minimum staffing
levels at 0.55 HPRD for RNs and 2.45 HPRD for NAs. In establishing this
proposal, we considered the context of substantial cost that the
proposed policy may impose on LTC facilities, especially those with
limited resources that may face difficult decisions in terms of how to
allocate funding and resources (see Regulatory Impact Section for more
detail). Likewise, the evidence from the 2022 Nursing Home Staffing
Study supports the proposed minimum staffing level for RNs and NAs for
improving safety and leading to higher quality care. As such, we are
proposing minimum nurse staffing standards for these two types of
nursing staff that we believe are reasonable and creates meaningful,
positive impact on resident quality and safety. These standards will
especially help ensure all facilities reach acceptable levels of safety
and quality care, working in tandem with CMS' other quality improvement
programs that focus on raising performance beyond minimum requirements.
The proposed minimum nurse staffing standards would create broadly
applicable minimum standards at which all residents across all LTC
facilities would be at a significantly lower risk of receiving unsafe
and low-quality care. LTC facilities would be required to staff above
these minimum adjusted baseline levels, as appropriate, to address the
specific needs of their unique resident population. This additional
staffing should be based at the facility level using the facility
assessment and an examination of resident acuity levels.
LTC facilities are also responsible for compliance with other
requirements for participation, including but not limited to Sec.
483.24, which requires that each resident must receive and the facility
must provide the necessary care and services to attain or maintain the
highest practicable physical, mental, and psychosocial well-being,
consistent with the resident's comprehensive assessment and plan of
care. Therefore, we propose to add a new Sec. 483.35(a)(1)(v) to
reinforce this standard. Specifically, at Sec. 483.35(a)(1)(v), we
propose to specify that compliance with minimum HPRD for RN and NA
should not be construed as approval for a facility to have fewer
nursing and non-nursing staff than the number of staff with the
appropriate competencies and skills sets necessary to assure resident
safety, and to attain or maintain the highest practicable physical,
mental, and psychosocial well-being of each resident, as determined by
resident assessments, acuity and diagnoses of the facility's resident
population in accordance with the facility assessment required at
current Sec. 483.70(e)), which we propose to be redesignate as new
Sec. 483.71.
The acuity and characteristics of residents in LTC facilities has
continued to evolve and change over the years. For example, there are
more residents with a psychiatric diagnosis with reports showing that
the proportion of residents with schizophrenia increased from 6.5
percent in 2000 to 12.4 percent in 2017.\89\ There has also been an
increase in the percentage of facilities with an Alzheimer's unit and
more residents appear to need assistance with activities of daily
living. For example, it was reported that on average 96 percent of
residents at the facility level needed assistance with bathing in 2015,
compared to the national average of 89 percent of residents in
1985.\90\ Also the percentage of residents with bladder incontinence
has also increased over the years from 49.3 to 62.1 percent.\3\
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\89\ M. Barton Laws, Aly Beeman, Sylvia Haigh, Ira B. Wilson,
Ren[eacute]e R. Shield, Prevalence of Serious Mental Illness and
Under 65 Population in Nursing Homes Continues to Grow. Journal of
the American Medical Directors Association,Volume 23, Issue 7, 2022,
Pages 1262-1263, <a href="https://doi.org/10.1016/j.jamda.2021.10.020">https://doi.org/10.1016/j.jamda.2021.10.020</a>.
\90\ Fashaw, Shekinah A et al. ``Thirty-Year Trends in Nursing
Home Composition and Quality Since the Passage of the Omnibus
Reconciliation Act.'' Journal of the American Medical Directors
Association vol. 21,2 (2020): 233-239. doi:10.1016/
j.jamda.2019.07.004.
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Furthermore, there appears to be an increase in the proportion of
younger residents, under 65 years of age, in part due to severe mental
illness and substance use disorders, who have different needs from the
traditional nursing home population.\91\ Given the variation in
resident acuity and complexity of care required for a facility's unique
resident population, facilities must make thoughtful, informed staffing
plans and decisions that are focused on meeting resident needs,
including maintaining or improving resident safety and quality of life,
which will often result in the need for a facility to staff above the
minimum nurse staffing requirement. Based on the needs of its resident
population, an individual facility may need to maintain levels of HPRD
for RN, NA and other staffing that surpasses the proposed minimum nurse
staffing HPRD.
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\91\ Laws, M Barton et al. ``Changes in Nursing Home Populations
Challenge Practice and Policy.'' Policy, politics & nursing practice
vol. 23,4 (2022): 238-248. doi:10.1177/15271544221118315.
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This need for increased staff would be evidenced by the facility
assessment (Sec. 483.70(e)) and resident assessments (Sec. 483.20)
which would require facilities to make staffing and care planning
decisions that account for resident acuity, physical/cognitive
abilities, conditions, diagnoses, etc . . . Compliance with the
numerical minimum staffing requirement is necessary but not necessarily
sufficient to meet staffing needs for every facility. Later in this
proposed rule, we discuss an additional element of this comprehensive
proposal, revising the facility assessment requirement at Sec.
483.70(e) which we believe would help avoid the unintended consequence
of facilities inappropriately staffing at the minimum staffing
requirement.
We note that, as discussed previously, while the 0.55 and 2.45 HPRD
standards were developed using case-mix adjusted data sources, the
standards themselves will be implemented and enforced independent of a
facility's case-mix. In other words, facilities must meet the 0.55 RN
and 2.45 NA HPRD standards, regardless of the individual facility's
patient case-mix. Based on the October 2021 Care Compare data, we
estimate that approximately 6,094 facilities are staffed below a level
of 0.55 for RNs, and approximately 9,998 are currently staffed below a
level of 2.45 for NAs out of an estimated 14,688 total facilities with
complete information. These estimates do not reflect proposed
exemptions discussed below. Similarly, we recognize that there are
facilities currently staffing at levels greater than or equal to 0.55
RN HPRD (n=8,594) and 2.45 NA HPRD (n=4,690) who would not be directly
impacted by this proposed policy at this time. However, staffing should
be assessed on an ongoing basis and we emphasize that

[[Page 61370]]

the facility must provide adequate nursing care to meet the needs of
each resident.
Typical characteristics of LTC facilities that may need to staff up
to meet this minimum requirement, based on having current staffing,
below the proposed levels are:
<bullet> For-profit facilities (compared to government and non-
profit facilities).
<bullet> Larger facilities.
<bullet> Freestanding LTC facilities (relative to hospital-based).
<bullet> Facilities that are part of a Continuing Care Retirement
Community.
<bullet> Facilities with higher shares of Medicaid residents.
<bullet> Facilities that are Special Focus Facilities (SFF) or SFF
candidates.
<bullet> Rural facilities.
We note that the existing statutory waiver for Medicaid NFs,
authorized by section 1919(b)(4)(C)(ii) of the Act and implemented at
Sec. 483.35(e) for a State to waive the requirements of Sec.
483.35(b) to provide licensed nurses on a 24-hour basis would still be
in place for NFs to pursue through the current waiver process. The
statutory waiver is discussed further under Section II.B. 3. ``Hardship
Exemption from the Minimum Hours Per Resident Day Requirements for RNs
and NAs.'' In addition, we propose to add new paragraphs (a)(1)(iii)
and (iv) to existing Sec. 483.35 to specify that facilities may be
exempted from the minimum HPRD requirement for RNs and NAs using
separate criteria, and to indicate the period of time that will be
assessed to determine compliance.
At new Sec. 483.35(a)(1)(iii), we propose facilities that are
found non-compliant with the HPRD requirement for RNs and NAs and meet
certain eligibility criteria may be exempted from the 0.55 HPRD for RNs
and/or 2.45 HPRD for NAs requirements. The details of this exemption
framework and the specific eligibility criteria are discussed further
in section II.B.3. ``Hardship Exemption from the Minimum Hours Per
Resident Day Requirements for RNs and NAs.'' of this rule. At new Sec.
483.35(a)(1)(iv), we propose that determinations of compliance with
minimum HPRD requirements for RNs and NAs will be made based on the
most recent available quarter of PBJ System data submitted in
accordance with the requirements at existing Sec. 483.70(p)
(``Mandatory Submission of Staffing Information Based on Payroll Data
in a Uniform Format'').
We solicit comments on the timeframe used to determine compliance
with the minimum HPRD, specifically if the lookback period should be
longer, for example 1 year to cover a full certification period, or
some other timeframe to ensure the most reliable and realistic
assessment of staffing data. We also invite public comments on the
following proposals discussed in this section. As highlighted
throughout the discussion, we acknowledge multiple avenues for
establishing a minimum nurse staffing requirement. Based on the
proposed policy presented in this rule, we are seeking feedback
regarding whether or not alternative policy options are necessary to
meet and maintain acceptable quality and safety within LTC facilities,
while balancing a facility's ability to comply and ensure access to
care.
In developing the proposed rule, we considered varying staffing
models that are available and different approaches we could have
adopted for establishing minimum nurse staffing standards. For example,
we could have adopted multiple different types of combinations of
staffing requirements, such as a four-part requirement (inclusive of a
total nurse staffing ratio, RNs, LPN/LVNs, and NAs) or a three-part
requirement (inclusive of a total nursing staffing ratio, RNs, NAs or
separate standards for RNs, LPN/LVNs, and NAs). We also considered that
LTC facilities differed across States in their reliance on LPN/LVNs,
which was one of the reasons that we did not set a minimum requirement
for LPN/LVNs, in addition to available evidence on LPN/LVN associations
with safety and high--quality care. Alternatively, we could have
proposed staffing requirements for professionals such as social
workers, therapists, feeding assistants and other non--nurse staff in
the minimum staffing requirement. However, the HPRD reported in PBJ
System data for non-nurse staff were insufficient for use in
establishing minimum staffing requirements at this time.
We propose to use HPRD that LTC facilities self-report to CMS and
currently reported and auditable in the CMS' PBJ System. However, we
recognize that staffing levels can be measured in at least 19 different
ways with HPRD being the most frequently used.\92\ This includes
measuring staffing levels as either full time equivalent per resident,
full time equivalent per 100 beds, minutes per resident day, or nursing
staff to resident ratios. Alternative minimum staffing policy options
could also focus on the need to increase or decrease the number of HPRD
or FTEs by nurse staff and/or type or on specifying the number by shift
(including day, evening, night, or weekends or over a 24-hour period).
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\92\ Clemes, S., Wodchis, W., McGilton, K., McGrail, K., &
McMaho, M. (2021). The relationship between quality and staffing in
long-term care: A systematic review of the literature 2008-2020.
International Journal of Nursing Studies, 122, <a href="https://doi.org/10.1016/j.ijnurstu.2021.104036">https://doi.org/10.1016/j.ijnurstu.2021.104036</a>.
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We are soliciting comments on establishing a total nurse staffing
standard such as 3.48 HPRD among other alternatives, in place of a
requirement only for RNs and NAs, or in addition to a requirement for
RNs and NAs. For example, we considered an alternative 3.48 HPRD for
the total nurse staffing standard--inclusive of the 0.55 HPRD RN and
2.45 HPRD NA minimum standards--based on the evidence from the 2022
Nursing Home Staffing Study, in addition to other factors discussed
throughout the proposed rule. We considered 0.55 HPRD for RNs and 2.45
HPRD for NAs as a part of this alternative total nurse staffing
standard based on the evidence from the 2022 Nursing Home Staffing
Study and other inputs; 0.55 HPRD for RN and 2.45 HPRD for NA staffing
were found to be positively associated with safety and quality.
Furthermore, NAs spend the most time providing care to residents by
assisting with activities of daily living (for example, feeding,
bathing, and dressing). Including an overarching minimum total staffing
standard, such as 3.48 HPRD, could enable LTC facilities flexibility on
staffing while protecting residents from preventable negative outcomes
and would discourage facilities that currently meet the individual RN
and NA minimums from decreasing total staffing. We seek comments on the
necessity of a total staffing standard and whether a total staffing
standard should be adopted alongside individual standards. We
specifically seek comment on a standard of 3.48 HPRD among other
alternatives.
To maximize the usefulness of the feedback from interested parties
on alternative policy options, we emphasize that the recommended policy
must support and promote acceptable quality and safety in LTC
facilities as the intended goal. We seek comments on the effectiveness
of a minimum staffing standard in maintaining quality and safety and
ways to minimize administrative burden, both for LTC facilities and for
CMS in maintaining and enforcing such a standard and enhance compliance
among LTC facilities through the use of automated data collection
techniques or other forms of information technology.
We encourage commenters to submit evidence and data to support
their recommendations to the extent possible. All comments will be
reviewed and analyzed, including consideration for

[[Page 61371]]

potential future rulemaking. We welcome comments on the following
questions:
<bullet> What are the benefits and trade-offs associated with a
two-part minimum nurse staffing standard as proposed (inclusive of RNs
and NAs) relative to a three-part standard (inclusive of a 3.48 HPRD
for total nurse staffing, RNs, and NAs) or a four-part standard
(inclusive of a total nurse staffing ratio, RNs, LPNs/LVNs, and NAs)?
<bullet> What evidence did States rely on when they adopted their
specific minimum nurse staffing standards, both with respect to HPRD
and the inclusion or exclusion of certain nursing staff, and what is
the rate of compliance?
<bullet> Whether we should consider a case-mix adjusted staffing
HPRD for each facility to assess compliance with the minimum staffing
standards? A case-mix adjusted staffing HPRD would adjust the minimum
staffing levels based on the health status of the residents in each
facility (known as ``case-mix adjustment''). Specifically, the case-mix
adjustment methodology aggregates data from each resident's assessment
(the Minimum Data Set (MDS)) to identify the general level of acuity of
each facility's residents. The level of acuity is then combined with
the facility's self-reported (that is, unadjusted) staffing information
to calculate the level of staff the facility has that is equivalent to
other facilities.
If we were to adjust the minimum staffing levels based on the
health status of the residents in each facility to ensure that staffing
levels are adequate to meet the unique needs of the residents in each
facility--
<bullet> What steps can CMS take to support LTC facilities in
predicting what their case-mix adjusted staff might be and hire in
expectation of that adjusted staffing level? What resources will
facilities need to proactively calculate their existing HPRD for
nursing staff, and what may be needed?
<bullet> What alternative policies or strategies should we consider
to ensure that we enhance compliance, safeguard resident access to
care, and minimize provider burden? Are there are other alternative
policy strategies we should consider?
b. Registered Nurse (Sec. 483.35(b)(1))
The existing LTC facility staffing regulations require an RN to be
on site 8 consecutive hours a day for 7 days a week (Sec.
483.35(b)(1)).\93\ This requirement serves as a minimum to protect the
health and safety of LTC facility residents. In other words, an RN is
required to be onsite for a total of 8 consecutive hours out of 24
hours a day. The LTC facility may decide to allocate all 8 consecutive
hours of RN time to one day shift or an evening shift for a 24-hour
day, similarly to the HPRD proposed for RNs.
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\93\ 42 CFR 483.35, <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2022/02/28/fact-sheet-protecting-seniors-and-people-with-disabilities-by-improving-safety-and-quality-of-care-in-the-nations-nursing-homes/">https://www.whitehouse.gov/briefing-room/statements-releases/2022/02/28/fact-sheet-protecting-seniors-and-people-with-disabilities-by-improving-safety-and-quality-of-care-in-the-nations-nursing-homes/</a>.
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However, to prevent avoidable patient safety events, some
organizations have recommended higher recommendations to each RN
staffing levels. For example, in 2022, the National Academies of
Science, Engineering, and Medicine (NASEM) published a report that
recommended direct-care RN coverage 24 hours a day, 7 days a week.\94\
Like NASEM, we are concerned that even with minimum HPRD standards,
these residents are at risk for preventable safety events when there is
no RN on site, particularly during evenings, nights, weekends, and
holidays. Therefore, to avoid placing LTC facility residents at risk of
preventable safety events due to the absence of an RN, we are proposing
to revise Sec. 483.35(b)(1) to require LTC facilities to have an RN
onsite 24 hours a day, 7 days a week.
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\94\ National Academies of Sciences, Engineering, and Medicine.
2022. The National Imperative to Improve Nursing Home Quality:
Honoring Our Commitment to Residents, Families, and Staff.
Washington, DC: The National Academies Press. <a href="https://doi.org/10.17226/26526">https://doi.org/10.17226/26526</a>.
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LTC facilities provide care for residents with increasing medically
complex and acute health conditions that require substantial resources
and care. This care is provided or supervised by an RN. In the FY 2016
final rule, we indicated that CMS was proposing changes to the LTC
facility participation requirements to ensure that LTC facilities are
providing quality and safe care to medically complex residents among
others (81 FR 68688). We noted that not only has the acuity of the
resident population generally increased, but there has also been a
dramatic increase in the number of residents recovering from an acute
episode of major surgery, injury, or illness (sub-acute resident
population).
Medicare payment policy has also contributed to higher acuity
levels in LTC facilities. After Medicare implemented the prospective
payment system for hospitals in 1983, there were shorter hospital stays
for Medicare beneficiaries and increased funding for post-acute stays
in LTC facilities (80 FR 42168, 42174-42175). This payment policy
resulted in a growing sub-acute resident population in LTC facilities
that would have previously experienced longer hospital stays. Also,
with the increase in alternatives to LTC facilities, such as assisted-
living facilities and home care, LTC facilities are caring for more
dependent residents who require more complex basic medical care and
rehabilitative services. In addition, LTC facilities are caring for a
significant number of residents with dementia, depression, or other
behavioral health issues. LTC facilities today have even been referred
to as ``mini-hospitals.'' \95\
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\95\ Three challenges of long-term care (LTC) nursing. Health.
Accessed at <a href="https://www.wolterskluwer.com/en/expert-insights/three-challenges-of-longterm-care-ltc-nursing">https://www.wolterskluwer.com/en/expert-insights/three-challenges-of-longterm-care-ltc-nursing</a>. Published on May 5, 2015.
Accessed on February 13, 2023.
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While RNs and LPNs/LVNs appear to provide some similar nursing
services, such as administering medications, there are crucial
differences. Compared to LPNs and LVNs, RNs' scope of practice is
broader and they receive more education.\96\ Most importantly, RNs
practice independently and are qualified to conduct clinical nursing
assessments, whereas LPNs and LVNs require an RN or a physician's
supervision. This is a critical feature in the RN scope of practice
given the higher acuity of today's LTC facility resident population and
the need to properly clinically assess residents to ensure they are
receiving the appropriate care. Also, it has been reported in the
literature that LPN/LVNs may find themselves practicing outside their
scope of practice when there is not sufficient RN staffing in a
facility to provide direct or supervised resident care (80 FR 42168,
42200). Thus, we are also proposing that the RN be available to provide
direct resident care around the clock.
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\96\ Jividen, S. RN vs. LPN. <a href="http://Nurse.org">Nurse.org</a>. Accessed at <a href="https://nurse.org/resources/rn-vs-lpn/">https://nurse.org/resources/rn-vs-lpn/</a>. Published on July 15, 2021. Accessed
on February 13, 2023.
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For several decades, studies and gray literature materials other
than traditional research publications, such as opinion pieces,
advocacy materials, and non-statistically rigorous research published
by government agencies have recommended an RN onsite 24-7 in LTC
facilities for similar reasons. As noted previously in this proposed
rule, the 2022 NASEM report, recommended that LTC facilities have 24
hours a day, 7 days a week RN onsite coverage. NASEM noted that most
LTC facilities provide care for both short-term residents who require
rehabilitation or subacute care and long-term care for residents. While
the acuity of short-term residents would vary greatly depending upon
their reason for admission and condition, NASEM noted that the long-
term care residents typically have multiple chronic conditions that
require professional nursing surveillance to

[[Page 61372]]

monitor the residents for changes that might require hospitalization or
potentially be life-threatening.\97\ As noted previously in this rule,
it is the RN that has the education, training, and qualifications to
conduct clinical nursing assessments. The report also suggested that
there be additional RN coverage when needed and that the DON not be
counted towards this requirement.
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\97\ FN #93, NASEM, p. 58.
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In the 2016 LTC facility final rule,\98\ we noted that several
commenters, including the Center for Medicare Advocacy and the
California Advocates for Nursing Home Reform, recommended that LTC
facilities have 24-hours RN onsite coverage. These commenters argued
that 24-hours RN coverage was necessary due to the increased acuity in
residents and that expert nursing skill is needed to ``anticipate,
identify and respond to changes in [a resident's] condition,'' as well
as for the residents to have appropriate rehabilitation services and
the best chance for being discharged home in a safe and timely manner
(80 FR 68754). Other commenters noted that RN staffing was essential
for safe and effective resident care.\99\ While we agreed with the
commenters on the importance of staffing, and noted that due to their
education and licensure, RNs possess the skills that are ``essential
for timely assessment, intervention and treatment,\100\ we did not
establish a minimum nursing staff standard at that time for the reasons
noted in the 2016 final regulation. Instead, at Sec. 483.35, we
finalized an approach that required the LTC facility to have sufficient
nursing staff to assure safety and well-being of each resident as
determined by resident assessments and individual plans of care and
considering the number and acuity of diagnoses of the facility's
resident population in accordance with the facility assessment required
at Sec. 483.70(e). Among other reasons, we did not propose a 24-hour
RN onsite requirement due to lack of sufficient data including PBJ
System data. As discussed previously in this proposed rule, we did not
yet have the data from the PBJ System or another reliable source upon
which to base a minimum staffing requirement. We now also have the Abt
study discussed above that demonstrated the importance of RNs to the
quality-of-care residents receive. Others, including professional
nursing organizations, also contended that the requirements should be
focused on resident acuity and the competencies and skill sets of the
nursing staff than a specific numerical requirement for categories of
staff (80 FR 42168, 42200 and 42201). We were also concerned that some
LTC facilities, especially those in rural and underserved areas, might
find complying with such a requirement especially challenging (81 FR
68694, 68752, 68755).
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\98\ Medicare and Medicaid Programs; Report of Requirements for
Long-Term Care Facilities. 81 FR 68688. Published on October 4,
2016.
\99\ FN #24, p. 68754.
\100\ FN #24, p. 68754.
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We also heard these same concerns reiterated in the FY 2023 SNF PPS
RFI comments and the interested parties listening sessions discussed
previously. These commenters noted that RNs, by the virtue of their
education and training, have diagnostic and assessment skills that
other types of nurse staff do not. They noted that LTC facilities have
populations with the highest needs and complex medical issues and the
availability of RNs for resident assessments is necessary and could
prevent avoidable resident hospitalizations. Based on comments received
in the FY 2023 SNF PPS RFI, NASEM's recommendations, and other gray and
peer-reviewed literature, we propose that all LTC facilities must have
an RN onsite 24 hours a day, 7 days a week at Sec. 483.35(b)(1).
An existing statutory waiver for Medicare SNFs, set out at section
1819(b)(4)(C)(ii) of the Act and implemented at Sec. 483.35(f),
permits the Secretary to waive the requirements of Sec. 483.35(b) to
provide the services of a RN for more than 40 hours a week, including
the director of nursing. This waiver would still be in place for SNFs
to pursue through the current waiver process. Facilities would also use
this process to pursue a waiver of the 24 hours a day, 7 days a week
requirement. However, we discuss certain criteria that may exempt a LTC
facility (SNF or NF) from meeting the proposed HPRD levels for RNs and
NAs specifically established in Sec. 483.35(a)(1)(i) and (ii) in
section III.B.4 of this rule. We welcome comments regarding our
proposed requirements for each LTC facility to have an RN on site 24
hours a day, 7 days a week that is available for direct resident care.
In addition to our proposed 24-hour, 7 days a week requirement for
an RN, we continue to maintain a separate requirement for the DON. All
LTC facilities must designate an RN to serve as the DON on a full-time
basis (Sec. 483.35(b)(2)). The current rule stipulates that the DON
can serve as a charge nurse only if the facility has an average daily
occupancy of 60 or fewer residents (Sec. 483.35(b)(3)). Since the DON
must be an RN, the DON is included in the proposed nurse minimum
staffing requirements as an RN. All RNs with administrative duties,
including the DON, should be available for direct resident care when
needed. However, the DON, as well as other nurses with administrative
duties, would probably have limited time to devote to direct resident
care. We are concerned that for some LTC facilities having the DON as
the only RN on site might be insufficient to provide safe and quality
care to residents. This concern was also expressed in the NASEM 2022
publication discussed previously, in which the NASEM recommended that
the DON not be counted in the requirement for an RN 24 hours, 7 days a
week.\101\ All comments regarding these questions will be reviewed and
analyzed, including consideration for potential future rulemaking.
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\101\ National Academies of Sciences, Engineering, and Medicine.
2022. The National Imperative to Improve Nursing Home Quality:
Honoring Our Commitment to Residents, Families, and Staff,
Recommendation 2B.
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We welcome comments on the following questions:
<bullet> Does your facility, or one you are aware of, have an RN
onsite 24 hours a day, 7 days a week? If not, how does the facility
ensure that staff with the appropriate skill sets and competencies are
available to assess and provide care as needed?
<bullet> If a requirement for a 24 hour, 7 day a week onsite RN who
is available to provide direct resident care does not seem feasible,
could a requirement more feasibly be imposed for a RN to be
``available'' for a certain number of hours during a 24 hour period to
assess and provide necessary care or consultation provide safe care for
residents? If so, under what circumstances and using what definition of
``available''?
<bullet> Should the DON be counted towards the 24/7 RN requirement
or should the DON only count in particular circumstances or with
certain guardrails? Please explain why or why not.
<bullet> Are there alternative policy strategies that we should
consider to address staffing supply issues such as nursing shortages?
2. Administration (Sec. 483.70)
We believe that a comprehensive approach to establishing staffing
requirements is necessary to ensure that facilities are making
thoughtful, informed staffing plans and decisions to support the
health, safety, and well-being of residents. In particular, we want to
avoid unintended consequences of establishing a minimum nurse

[[Page 61373]]

staffing requirement that could lead to a regression by those
facilities currently staffing above the staffing requirement or
facilities only staffing at the minimum level proposed without
considering whether resident acuity or resident census, requires
additional staffing above that floor. It is our expectation that LTC
facilities will consider their capabilities and capacity, as well as
the number, acuity, and diagnoses of their residents when developing
staffing schedules.
As previously discussed, in 2016, we released a final rule that
revised the requirements that LTC facilities must meet to participate
in the Medicare and Medicaid Programs.\102\ As part of those revisions,
we finalized revisions at Sec. 483.70(e), Administration, to require
facilities to conduct, document, and annually review a facility-wide
assessment to determine what resources are necessary to care for its
residents competently during both day-to-day operations and
emergencies. This facility-wide assessment requires LTC facilities to
determine adequate staffing type and level based on the number of
residents, resident acuity, range of diagnoses, the content of care
plans, and other factors. LTC facilities are also required to address
and document in their facility assessments their resident population
(that is, number of residents, overall types of care and staff
competencies required by residents, and cultural aspects), resources
(for example, equipment, and overall personnel), and a facility-based
and community-based risk assessment.
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\102\ <a href="https://www.federalregister.gov/documents/2016/10/04/2016-23503/medicare-and-medicaid-programs-reform-of-requirements-for-long-term-care-facilities">https://www.federalregister.gov/documents/2016/10/04/2016-23503/medicare-and-medicaid-programs-reform-of-requirements-for-long-term-care-facilities</a>.
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While we assumed when we finalized the 2016 rule that most LTC
facilities already conducted some type of facility assessment of the
resident population and resources required as part of their normal
strategic planning, our revisions aimed to ensure that facilities had a
formal process for consistently conducting and documenting these
assessments and keeping them up-to-date. The formal facility assessment
process requires facilities to make thoughtful, person-centered
staffing plans and decisions focused on meeting resident needs that may
help improve the safety of residents. We believe this approach will
help facilities comply with the requirement to have sufficient staff,
which is investigated during surveys.
One of the goals of the 2016 revisions to the LTC facility
participation requirements for health and safety was to ensure that our
regulations align with current clinical practice and allow flexibility
to accommodate multiple care delivery models to meet the needs of
diverse populations that receive services in these facilities. As noted
previously, given the limitations of the PBJ System data in 2016, we
enacted a competency-based approach in the 2016 final rule, that
focused on achieving the statutorily mandated outcome of ensuring that
each resident is provided care that allows the resident to maintain or
attain their highest practicable physical, mental, and psychosocial
well-being. The facility assessment requirement was central to the
revised 2016 LTC facility participation requirements, and was intended
to be used by the facility for multiple purposes, including, but not
limited to, determining adequate staffing and other resources,
establishing a Quality Assurance and Performance Improvement (QAPI)
program, and conducting emergency preparedness planning.
Our expectation was that the application and development of the
facility assessment requirement and competence-based staffing decisions
would involve every service provided by a LTC facility and apply to all
staff, including the interdisciplinary team. For example, a facility
that provides dementia care would need to ensure that it has a
sufficient number of staff with the necessary skill sets and
competencies to care for individuals living with dementia. In addition,
CMS intended for facilities to use the facility assessment as a
resource and planning tool for both short-term (day-to-day) and long-
term (strategic) purposes.
As part of the FY2023 SNF PPS proposed rule, we sought public input
on how the facility assessment requirement should impact the minimum
staffing requirement (87 FR 22720). Many commenters suggested that the
facility assessment requirement should be used to complement the
minimum staffing requirement and to determine any additional nursing
staff that the facility needs, based on the acuity and needs of its
resident population. Other commenters shared concerns that the Federal
regulations established in 2016 requiring nursing homes to conduct a
facility self-assessment have never been adequately enforced or
surveyed.
As discussed earlier in this proposed rule, the recent 2022 Nursing
Home Staffing Study \103\ included in-person interviews and surveys
with facility leadership, direct care staff, and residents and their
family members to better understand the relationship among nurse
staffing levels, staffing mix, and the safety and quality of resident
care. During interviews, staff respondents (RNs, LPNs, NAs) were asked
to identify the number of residents that they could provide with
quality and safe care and to recommend minimum staffing requirements.
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\103\ Abt Associates. (2022). Nursing Home Staffing Study
Comprehensive report. Report prepared for the Centers for Medicare
and Medicaid Services <a href="https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf">https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf</a>.
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Respondents consistently noted that resident acuity was more important
than the actual number of assigned residents in determining whether
they could provide quality and safe care based on their staffing
assignments. Some respondents suggested minimum staffing requirements
in terms of the number of residents per shift/unit, accounting for
acuity, that they could safely manage and reported that their usual
shift/unit is frequently short-staffed. Some respondents also reported
concerns about a potential minimum staffing requirement being set too
low, fearing that administrators will understaff shifts, or that the
minimum will become the maximum.
Furthermore, we share the concern that there may be facilities who
currently exceed the proposed minimum staffing level and could
potentially be perversely incentivized to lower their staffing levels
to the required minimum staffing levels, rather than continuing to
staff above that level to meet the unique care needs of their
residents. Therefore, we underscore that in addition to meeting the
proposed minimum staffing levels, the facility assessment must continue
to be used to determine the necessary resources and staff that the
facility requires to care for its residents, regardless of whether or
not the facility is staffed at or above the new minimum staffing
requirement. Furthermore, we emphasize that a LTC facility's staffing
decisions should be based on the specific needs of its resident
population and not motivated by cost-savings. Thus, while each LTC
facility must comply with the minimum nurse staffing requirements set
forth at Sec. 483.35(a), unless the facility qualifies for a hardship
exemption under Sec. 483.35(g), the facility must also provide
sufficient staff (RNs, licensed nurses, and NAs) to provide nursing
care to all residents in accordance with the residents' assessments and
individual care plans (Sec. 483.35--introductory statement). Lastly,
we note that this proposed rule is not intended to, and would not
preempt the applicability of any State or local law providing a higher
standard (in this case, a higher HPRD ratio or an RN

[[Page 61374]]

coverage requirement in excess of one RN on site 24-hours per day, 7
days a week) than would be required by these proposed rules. To the
extent Federal standards exceed State and local minimum staffing
standards, no Federal pre-emption is implicated because facilities
complying with Federal law would also be in compliance with State law.
We are not aware of any State or local law providing for a maximum
staffing level. However, we note that this proposed rule is intended to
and would preempt the applicability of any State or local law providing
for a maximum staffing level, to the extent that such a State or local
maximum staffing level would prohibit a Medicare and Medicaid certified
LTC facility from meeting the minimum HPRD ratios and RN coverage
levels proposed in this rule.
To ensure that facilities are utilizing the facility assessment as
intended, we are proposing to redesignate the existing requirements for
the facility assessment to its own standalone section from Sec.
483.70(e) to proposed Sec. 483.71. We note that we are also proposing
technical changes throughout the CFR to replace references to Sec.
483.70(e) with Sec. 483.71 based on this proposed change. Given the
importance of the facility assessment requirement and the multiple
program ways in which the assessment may be used to inform a facility's
decision-making and planning, we believe that the requirements should
be set out as a standalone section rather than in the Administration
section. In addition, while the responsibility to implement and utilize
the facility assessment to inform facility operations belongs to the
facility's administrator and governing body, we acknowledge that a
multitude of facility leadership and management contribute to the
development of the assessment given its importance and broad
applicability.
In addition to redesignating (this is, relocating or moving) the
existing requirements to a standalone section, we are also proposing
clarifications throughout the section to further specify what the
facility assessment must be used for. We propose to redesignate the
stem statement for current Sec. 483.70(e) to the stem statement for
proposed Sec. 483.71. Existing paragraphs Sec. 483.70(e)(1) through
(3) identify the key elements of the facility assessment and specify
the considerations that the assessment must account for, including the
facility's resident population, resources, and the facility and
community-based risk assessment which is required to complete as part
of the facility's emergency planning. This includes using their
assessment of resident needs to determine the competencies and skill
sets their staff needs to provide safe and quality care for the
residents. The LTC facility should also use the information from the
facility assessment to determine their training needs for its staff. We
propose to redesignate Sec. 483.70(e)(1) through (3) as proposed Sec.
483.71(a)(1) through (3), respectively. We note the discussion of the
proposed revisions follows the organization of the requirements as
presented in the new standalone section we are proposing at Sec.
483.71.
At new paragraph Sec. 483.71(a)(1)(ii), we propose to clarify that
facilities would have to address in the facility assessment details of
its resident population, including the care required by the resident
population, using evidence-based, data driven methods that consider the
types of diseases, conditions, physical and behavioral health issues,
cognitive disabilities, overall acuity, and other pertinent facts that
are present within that population, consistent with and informed by
individual resident assessments as required under existing Sec. 483.20
``Resident Assessment.''. Specifically, we propose to revise this
paragraph by specifying the ``use of evidence-based, data driven
methods'' and create a link to the requirements for the resident
assessment. Facilities are expected to update their facility assessment
as needed, no less than annually, using evidence-based, data-driven
methods, that consider the needs of their residents and the
competencies of their staff. For example, facilities need to be able to
describe residents' acuity levels in order to understand the care and
services required, and we would expect that they refer to data sources
such as the resident assessments; comprehensive care plans; MDS; RUG-IV
categories, if available; or, other resident acuity tools. Assessing
acuity levels and effectively using MDS and discharge planning are also
an important part of ensuring that an individual can return to the
community whenever possible in the least restrictive environment.
In addition, existing regulations at Sec. 483.40 require LTC
facilities to provide each resident with the necessary behavioral
health care and services for the resident to attain or maintain the
highest practicable physical, mental, and psychosocial well-being, in
accordance with his or her comprehensive assessment and plan of care.
Hence, we also propose to revise this paragraph to add ``behavioral
health issues'' to clarify that LTC facilities must consider their
residents' physical and behavioral health issues. We are also concerned
with issues of inaccurate MDS coding of residents with a diagnosis of
schizophrenia and are taking action to reduce the inappropriate use of
antipsychotics without clinical indication in nursing homes.\104\
Therefore, we believe these revisions are necessary to ensure that
facilities are providing residents with appropriate services and care
for behavioral health. At new Sec. 483.71(a)(1)(iii), we propose to
add ``and skill sets'' so the requirement reads, ``(iii) The staff
competencies and skill sets that are necessary to provide the level and
types of care needed for the resident population.'' At new Sec.
483.71(a)(3), we propose to add a cross-reference to the existing
requirements for facilities to conduct a facility and community-based
risk assessment as part of their emergency planning resources.
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\104\ <a href="https://www.cms.gov/files/document/qso-23-05-nh.pdf">https://www.cms.gov/files/document/qso-23-05-nh.pdf</a>.
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At new Sec. 483.71(a)(4), we propose to require facilities to
include the input of facility staff, including but not limited to
categories such as nursing home leadership, management, direct care
staff and their representatives, and staff providing other services. A
comprehensive assessment of what resources are required for a LTC
facility to provide safe care for its resident population requires the
input from facility staff familiar with all of its essential services.
Nursing staff working in facilities can provide information to facility
management regarding their caseload and how many residents they believe
they can safely provide quality care to on a daily basis. Nursing staff
are also familiar with the unique needs of their resident population
and can speak to the staffing needs at both a shift and unit level.
In addition, direct care employee representation in the facility
assessment is critically important to securing an accurate analysis of
staffing needs required to ensure resident health and safety. Direct
care employees and their representatives are uniquely positioned to
assess and communicate what staffing competencies and levels, as well
as equipment and other resources are needed to provide appropriate
care. These individuals have a unique understanding of the resident
population's health needs because of their on-the-ground knowledge of
residents' care needs and facility operations. As examples, direct care
employees have distinct perspectives into what additional training is
needed to manage increased acuity in resident

[[Page 61375]]

needs; what ethnic, cultural, and religious factors are critical to the
provision of culturally competent resident care; and how health
information technology may be better leveraged to deliver consistent,
quality care according to resident preferences.
Input into the facility assessment from any authorized
representatives of direct care employees serves several important
functions. Such representatives may sometimes be better positioned to
directly communicate about facility conditions and the needs of the
resident population on behalf of direct care employees who may fear
retaliation from their employer. There may also be circumstances where
direct care employees are not fluent in English or not familiar with
translating observations into resource categories and want a trusted
representative to enable open and effective communication in the
facility assessment. Alongside direct care employees, their
representatives may also help ensure facility assessments are up-to-
date and used to inform facility staffing.
Representatives of direct care employees may take different forms.
One scenario of representation may involve union workplaces where
employees have designated a union representative, such as an employee
or third-party elected local union representative, business agent, or
safety and health specialist. Representation may also arise in
workplaces without collective bargaining agreements where at least one
employee or a subset of employees have designated a representative from
amongst themselves or a third-party worker advocacy group, community
organization, local safety organization, or labor union to serve as
their representative in a facility assessment. For example, employees
may choose to authorize a union safety and health specialist to help
compile staff observations regarding unmet training needs or
communicate safety concerns regarding outdated medical equipment, which
they may not otherwise feel comfortable sharing as part of their direct
reflections on resident needs.
These benefits of enabling the participation of direct employee
representatives are consistent with the demonstrated positive
association between union representation and resident well-being.
According to a recent study, resident mortality and worker infection
rates were lower in nursing homes with union representation compared to
those without; specifically, the study found unions were associated
with 10.8 percent lower resident COVID-19 mortality rates and 6.8
percent lower worker infection rates.\105\ We are soliciting public
comments on additional studies and data that demonstrate the benefits
of the participation of direct employee representatives in the facility
assessment process.
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\105\ Dean, A., McCallum, J. et al. Resident Mortality And
Worker Infection Rates From COVID-19 Lower In Union Than Nonunion US
Nursing Homes, 2020-21. April 20, 2022. <a href="https://doi.org/10.1377/hlthaff.2021.01687">https://doi.org/10.1377/hlthaff.2021.01687</a>.
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Other staff, including but not limited to those in food and
nutrition, pharmacy, and facility services, could provide vital
information on essential services and resources required to care

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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.